Anesthesiology

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Code	Device name	Class	21 CFR	510(k) (3y)
BRW	Protector, Dental	Class 1	21 CFR 868.5820	3
BRX	Stool, Anesthesia	Class 1	21 CFR 868.6700	1
BRY	Cabinet, Table And Tray, Anesthesia	Class 1	21 CFR 868.6100	5
BSE	Analyzer, Gas, Helium, Gaseous-Phase	Class 2	21 CFR 868.1640	3
BSF	Absorber, Carbon-Dioxide	Class 1	21 CFR 868.5310	8
BSI	Algesimeter, Powered	Class 2	21 CFR 868.1040
BSJ	Mask, Gas, Anesthetic	Class 1	21 CFR 868.5550	51
BSK	Cuff, Tracheal Tube, Inflatable	Class 2	21 CFR 868.5750	40
BSN	Filter, Conduction, Anesthetic	Class 2	21 CFR 868.5130	9
BSO	Catheter, Conduction, Anesthetic	Class 2	21 CFR 868.5120	75
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Class 2	21 CFR 868.5150	152
BSR	Stylet, Tracheal Tube	Class 1	21 CFR 868.5790	32
BSY	Catheters, Suction, Tracheobronchial	Class 1	21 CFR 868.6810	116
BSZ	Gas-Machine, Anesthesia	Class 2	21 CFR 868.5160	189
BTB	Hook, Ether	Class 1	21 CFR 868.5420
BTC	Bag, Reservoir	Class 1	21 CFR 868.5320	19
BTI	Compressor, Air, Portable	Class 2	21 CFR 868.6250	74
BTK	Strap, Head, Gas Mask	Class 1	21 CFR 868.5560	6
BTL	Ventilator, Emergency, Powered (Resuscitator)	Class 2	21 CFR 868.5925	100
BTM	Ventilator, Emergency, Manual (Resuscitator)	Class 2	21 CFR 868.5915	209
BTO	Tube, Tracheostomy (W/Wo Connector)	Class 2	21 CFR 868.5800	128
BTP	Dropper, Ether	Class 1	21 CFR 868.5420	1
BTQ	Airway, Nasopharyngeal	Class 1	21 CFR 868.5100	19
BTR	Tube, Tracheal (W/Wo Connector)	Class 2	21 CFR 868.5730	241
BTS	Tube, Bronchial (W/Wo Connector)	Class 2	21 CFR 868.5720	6
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Class 2	21 CFR 868.5450	222
BTY	Calculator, Predicted Values, Pulmonary Function	Class 2	21 CFR 868.1890	64
BWB	Forceps, Tube Introduction	Class 1	21 CFR 868.5780	6
BWC	Needle, Emergency Airway	Class 2	21 CFR 868.5090	14
BWF	Spirometer, Therapeutic (Incentive)	Class 2	21 CFR 868.5690	108
BWL	Apparatus, Electronanesthesia	Class 3	21 CFR 868.5400
BXA	Analyzer, Gas, Water Vapor, Gaseous-Phase	Class 1	21 CFR 868.1975	2
BXH	Gauge, Gas Pressure, Cylinder/Pipeline	Class 1	21 CFR 868.2610	4
BXJ	Clip, Nose	Class 1	21 CFR 868.6225	4
BXK	Gas, Calibration (Specified Concentration)	Class 1	21 CFR 868.6400	32
BXL	Algesimeter, Manual	Class 1	21 CFR 868.1030	1
BXM	Stimulator, Nerve, Ac-Powered	Class 2	21 CFR 868.2775	4
BXN	Stimulator, Nerve, Battery-Powered	Class 2	21 CFR 868.2775	63
BXO	Transducer, Gas Pressure	Class 1	21 CFR 868.2900	2
BXP	Transducer, Gas Flow	Class 1	21 CFR 868.2885	7
BXQ	Rhinoanemometer (Measurement Of Nasal Decongestion)	Class 2	21 CFR 868.1800	12
BXR	Meter, Airway Pressure (Inspiratory Force)	Class 2	21 CFR 868.1780	6
BXW	Calibrator, Volume, Gas	Class 1	21 CFR 868.1870	6
BXX	Calibrator, Pressure, Gas	Class 1	21 CFR 868.2620	10
BXY	Flowmeter, Calibration, Gas	Class 1	21 CFR 868.2350	7
BYD	Condenser, Heat And Moisture (Artificial Nose)	Class 1	21 CFR 868.5375	73
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Class 2	21 CFR 868.5965	80
BYF	Mask, Oxygen, Low Concentration, Venturi	Class 1	21 CFR 868.5600	19
BYG	Mask, Oxygen	Class 1	21 CFR 868.5580	55
BYH	Drain, Tee (Water Trap)	Class 1	21 CFR 868.5995	22
BYI	Percussor, Powered-Electric	Class 2	21 CFR 868.5665	58
BYJ	Unit, Liquid-Oxygen, Portable	Class 2	21 CFR 868.5655	55
BYK	Tent, Oxygen, Electrically Powered	Class 2	21 CFR 868.5710	3
BYL	Tent, Oxygen	Class 1	21 CFR 868.5700	11
BYM	Tube, Thorpe, Uncompensated	Class 1	21 CFR 868.2320	1
BYN	Chair, Posture, For Cardiac And Pulmonary Treatment	Class 1	21 CFR 868.5365	1
BYO	Bottle, Blow	Class 1	21 CFR 868.5220	4
BYP	Mouthpiece, Breathing	Class 1	21 CFR 868.5620	25
BYR	Transducer, Gas Pressure, Differential	Class 1	21 CFR 868.2875	3
BYT	Ventilator, External Body, Negative Pressure, Adult (Cuirass)	Class 2	21 CFR 868.5935	21
BYW	Device, Rebreathing	Class 1	21 CFR 868.5675	2
BYX	Tubing, Pressure And Accessories	Class 1	21 CFR 868.5860	62
BZA	Connector, Airway (Extension)	Class 1	21 CFR 868.5810	94
BZB	Catheter, Nasal, Oxygen	Class 1	21 CFR 868.5350	8
BZC	Calculator, Pulmonary Function Data	Class 2	21 CFR 868.1880	90
BZD	Ventilator, Non-Continuous (Respirator)	Class 2	21 CFR 868.5905	461
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Class 2	21 CFR 868.5270	46
BZG	Spirometer, Diagnostic	Class 2	21 CFR 868.1840	228
BZH	Meter, Peak Flow, Spirometry	Class 2	21 CFR 868.1860	81
BZK	Spirometer, Monitoring (W/Wo Alarm)	Class 2	21 CFR 868.1850	61
BZL	Computer, Oxygen-Uptake	Class 2	21 CFR 868.1730	33
BZM	Calculator, Pulmonary Function Interpretor (Diagnostic)	Class 2	21 CFR 868.1900	26
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Class 1	21 CFR 868.6175	8
BZO	Set, Tubing And Support, Ventilator (W Harness)	Class 1	21 CFR 868.5975	88
BZQ	Monitor, Breathing Frequency	Class 2	21 CFR 868.2375	176
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Class 2	21 CFR 868.5330	55
BZS	Stethoscope Head	Class 1	21 CFR 868.1930	3
BZT	Stethoscope, Esophageal, With Electrical Conductors	Class 2	21 CFR 868.1920	46
BZW	Stethoscope, Esophageal	Class 1	21 CFR 868.1910	13
CAC	Apparatus, Autotransfusion	Class 2	21 CFR 868.5830	195
CAD	Vaporizer, Anesthesia, Non-Heated	Class 2	21 CFR 868.5880	57
CAE	Airway, Oropharyngeal, Anesthesiology	Class 1	21 CFR 868.5110	57
CAF	Nebulizer (Direct Patient Interface)	Class 2	21 CFR 868.5630	508
CAG	Circulator, Breathing-Circuit	Class 2	21 CFR 868.5250
CAH	Filter, Bacterial, Breathing-Circuit	Class 2	21 CFR 868.5260	202
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Class 1	21 CFR 868.5240	184
CAL	Laryngoscope, Non-Rigid	Class 1	21 CFR 868.5530	8
CAM	Yoke Assembly, Medical Gas	Class 1	21 CFR 868.6885	8
CAN	Regulator, Pressure, Gas Cylinder	Class 1	21 CFR 868.2700	55
CAO	Airway, Esophageal (Obturator)	Class 2	21 CFR 868.5650	6
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Class 2	21 CFR 868.2600	78
CAT	Cannula, Nasal, Oxygen	Class 1	21 CFR 868.5340	42
CAW	Generator, Oxygen, Portable	Class 2	21 CFR 868.5440	288
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Class 1	21 CFR 868.2340	24
CAZ	Anesthesia Conduction Kit	Class 2	21 CFR 868.5140	155
CBA	Monitor, Air Embolism, Ultrasonic	Class 2	21 CFR 868.2025	1
CBF	Chamber, Hyperbaric	Class 2	21 CFR 868.5470	69
CBG	Spreader, Cuff	Class 1	21 CFR 868.5760	1
CBH	Device, Fixation, Tracheal Tube	Class 1	21 CFR 868.5770	47
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Class 2	21 CFR 868.5740	34
CBK	Ventilator, Continuous, Facility Use	Class 2	21 CFR 868.5895	505
CBL	Absorbent, Carbon-Dioxide	Class 1	21 CFR 868.5300	5
CBN	Apparatus, Gas-Scavenging	Class 2	21 CFR 868.5430	43
CBO	Attachment, Intermittent Mandatory Ventilation (Imv)	Class 2	21 CFR 868.5955	15
CBP	Valve, Non-Rebreathing	Class 2	21 CFR 868.5870	103
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Class 2	21 CFR 868.1500	22
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Class 2	21 CFR 868.1700	5
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Class 2	21 CFR 868.1620	17
CBT	Arterial Blood Sampling Kit	Class 1	21 CFR 868.1100	58
CBZ	Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling	Class 2	21 CFR 868.1170	10
CCC	Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelli	Class 2	21 CFR 868.1150	15
CCE	Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling	Class 2	21 CFR 868.1200	23
CCI	Analyzer, Gas, Nitrogen, Gaseous-Phase	Class 2	21 CFR 868.1690	2
CCJ	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase	Class 2	21 CFR 868.1430	28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Class 2	21 CFR 868.1400	307
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Class 2	21 CFR 868.1720	122
CCM	Plethysmograph, Pressure	Class 2	21 CFR 868.1750	11
CCN	Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge	Class 1	21 CFR 868.2300	9
CCO	Bed, Rocking, Breathing Assist	Class 2	21 CFR 868.5180
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Class 1	21 CFR 868.5640	62
CCT	Applicator (Laryngo-Tracheal), Topical Anesthesia	Class 2	21 CFR 868.5170	10
CCW	Laryngoscope, Rigid	Class 1	21 CFR 868.5540	64
CCX	Support, Patient Position	Class 1	21 CFR 868.6820	8
ECX	Cylinder, Compressed Gas, And Valve	Class 1	21 CFR 868.2700	13
EPE	Brush, Cleaning, Tracheal Tube	Class 1	21 CFR 868.5795	2
FLS	Monitor, Apnea, Facility Use	Class 2	21 CFR 868.2377	16
FNC	Tent, Pediatric Aerosol	Class 2	21 CFR 868.5710	1
FOG	Hood, Oxygen, Infant	Class 1	21 CFR 868.5700	9
JAX	Pneumotachometer	Class 2	21 CFR 868.2550	8
JAY	Support, Breathing Tube	Class 1	21 CFR 868.5280	19
JED	Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling	Class 3	21 CFR 868.1120
JEF	Analyzer, Gas, Neon, Gaseous-Phase	Class 2	21 CFR 868.1670
JEG	Analyzer, Gas, Argon, Gaseous-Phase	Class 2	21 CFR 868.1075	1
JEH	Plethysmograph, Volume	Class 2	21 CFR 868.1760	11
JEZ	Monitor, Lung Water Measurement	Class 3	21 CFR 868.2450
JFE	Valve, Switching (Ploss)	Class 1	21 CFR 868.1965
JOH	Tube Tracheostomy And Tube Cuff	Class 2	21 CFR 868.5800	109
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Class 1	21 CFR 868.5460	20
KGB	Mask, Oxygen, Non-Rebreathing	Class 1	21 CFR 868.5570	13
KGK	Gas, Collecting Vessel	Class 1	21 CFR 868.1575	2
KHA	Mask, Scavenging	Class 1	21 CFR 868.5590	1
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Class 2	21 CFR 868.2500	47
KOI	Stimulator, Nerve, Peripheral, Electric	Class 2	21 CFR 868.2775	29
LKD	Monitor, Carbon-Dioxide, Cutaneous	Class 2	21 CFR 868.2480	17
LNZ	Changer, Tube, Endotracheal	Class 2	21 CFR 868.5730	1
LPP	Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under G	Class 2	21 CFR 868.2500	2
MAJ	Catheter, Percutaneous, Intraspinal, Short Term	Class 2	21 CFR 868.5120	6
MIA	Needle, Spinal, Short Term	Class 2	21 CFR 868.5150	10
MNR	Ventilatory Effort Recorder	Class 2	21 CFR 868.2375	164
MNS	Ventilator, Continuous, Non-Life-Supporting	Class 2	21 CFR 868.5895	47
MNT	Sv70 Ventilator	Class 2	21 CFR 868.5895	25
MOD	Accessory To Continuous Ventilator (Respirator)	Class 2	21 CFR 868.5895	16
MRN	Apparatus, Nitric Oxide Delivery	Class 2	21 CFR 868.5165	33
MRO	Apparatus, Nitric Oxide, Backup Delivery	Class 2	21 CFR 868.5165	4
MRP	Analyzer, Nitric Oxide	Class 2	21 CFR 868.2380	1
MRQ	Analyzer, Nitrogen Dioxide	Class 2	21 CFR 868.2385
MZT	Device, Heimlich Maneuver Assist	Class 2	21 CFR 868.5115	1
NDC	Calculator, Drug Dose	Class 2	21 CFR 868.1890	55
NFB	Conserver, Oxygen	Class 2	21 CFR 868.5905	71
NHJ	Device, Positive Pressure Breathing, Intermittent	Class 2	21 CFR 868.5905	26
NHK	Resuscitator, Manual, Non Self-Inflating	Class 2	21 CFR 868.5905	10
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Class 2	21 CFR 868.1500
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Class 2	21 CFR 868.1500	1
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Class 2	21 CFR 868.1500
NMA	Tube, Tracheal, Reprocessed	Class 2	21 CFR 868.5730
NMC	Mask, Ventilator, Non-Continuous, Reprocessed	Class 2	21 CFR 868.5905
NMR	Needle, Spinal, Short Term, Reprocessed	Class 2	21 CFR 868.5150
NNH	Needle, Conduction, Anesthesia, Reprocessed	Class 2	21 CFR 868.5150
NOU	Continuous, Ventilator, Home Use	Class 2	21 CFR 868.5895	7
NPF	Monitor, Apnea, Home Use	Class 2	21 CFR 868.2377	2
NQY	Ventilator, Continuous, Minimal Ventilatory Support, Home Use	Class 2	21 CFR 868.5895
NVO	Spacer, Direct Patient Interface	Class 2	21 CFR 868.5630	2
NVP	Holding Chambers, Direct Patient Interface	Class 2	21 CFR 868.5630	16
NXA	Tracheotomy Care Kit	Class 2	21 CFR 868.5800	1
OBN	Humidifier, Respiratory, Mask (Direct Patient Interface)	Class 2	21 CFR 868.5450	1
OEV	Cardiopulmonary Resuscitation Aid Kit	Class 2	21 CFR 868.5915
OFO	Airway Suction Kit	Class 1	21 CFR 868.6810
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Class 1	21 CFR 868.5240
OFQ	Anesthesia Kit	Class 2	21 CFR 868.5120
OFR	Tracheobronchial Suction Catheter Kit	Class 1	21 CFR 868.6810
OFS	Tracheal Suction Set	Class 1	21 CFR 868.6810
OFT	Spinal Epidural Anesthesia Kit	Class 2	21 CFR 868.5120
OFU	Spinal Anesthesia Kit	Class 2	21 CFR 868.5120
OFV	Regional Anesthesia Kit	Class 2	21 CFR 868.5120
OFZ	Blood Specimen Collection Kit (Excludes Hiv Testing)	Class 1	21 CFR 868.1100
OGA	Brachial Plexus Anesthesia Kit	Class 2	21 CFR 868.5140
OGB	Caudal Anesthesia Kit	Class 2	21 CFR 868.5140
OGC	Continuous Brachial Plexus Block Tray	Class 2	21 CFR 868.5150
OGD	Custom Anesthesia Tray	Class 2	21 CFR 868.5120
OGE	Epidural Anesthesia Kit	Class 2	21 CFR 868.5120
OGF	Glossopharyngeal Anesthesia Kit	Class 2	21 CFR 868.5120
OGG	Humidifier Nebulizer Kit	Class 2	21 CFR 868.5450
OGH	Laryngoscope Kit	Class 1	21 CFR 868.5540
OGI	Nasal Endotracheal Tube Holder Kit	Class 1	21 CFR 868.5770
OGJ	Nerve Block Tray	Class 2	21 CFR 868.5140
OGK	Orotracheal Intubation Guide Kit	Class 2	21 CFR 868.1400
OGL	Oxygen Administration Kit	Class 2	21 CFR 868.5655
OGP	Cricothyrotomy Kit	Class 2	21 CFR 868.5800
OGV	Tracheostomy Cleaning Tray	Class 2	21 CFR 868.5800
OGW	Tracheostomy Kit	Class 2	21 CFR 868.5800