| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| OLF | Medevac Use Oxygen Generator | 第 2 类 | 21 CFR 868.5440 | 1 |
| ONZ | Mechanical Ventilator | 第 2 类 | 21 CFR 868.5895 | 6 |
| OQU | Airway Monitoring System | 第 2 类 | 21 CFR 868.5730 | 3 |
| OYI | Non-Bronchoscopic Bronchoalveolar Lavage Catheter | 第 1 类 | 21 CFR 868.6810 | 1 |
| PDT | Burn Resuscitation Decision Support Software | 第 2 类 | 21 CFR 868.1890 | 2 |
| PHS | Oral Airway Assist | 第 1 类 | 21 CFR 868.5110 | |
| PHY | Sparse Sample Pk Profile And Dosing Software | 第 2 类 | 21 CFR 868.1890 | |
| PHZ | Abnormal Breath Sound Device | 第 2 类 | 21 CFR 868.1900 | 7 |
| PMB | External Airway | 第 2 类 | 21 CFR 868.5105 | 1 |
| PNV | Impedance Measuring Device Utilizing Oscillation Techniques | 第 2 类 | 21 CFR 868.1840 | 4 |
| PRK | Device Indicating An Exhalation Event | 第 2 类 | 21 CFR 868.2375 | 1 |
| PUG | Analyzer, Nitrogen Dioxide, Exempt | 第 2 类 | 21 CFR 868.2385 | |
| PXE | Pressure Monitoring (Air/Gas) Kit | 第 1 类 | 21 CFR 868.2610 | |
| QAV | High Flow/High Velocity Humidified Oxygen Delivery Device | 第 2 类 | 21 CFR 868.5454 | 3 |
| QBY | Positive Airway Pressure System | 第 2 类 | 21 CFR 868.5273 | 2 |
| QCX | Retrograde Intubation Set | 第 2 类 | 21 CFR 868.5095 | 1 |
| QEB | Ventilatory Electrical Impedance Tomograph | 第 2 类 | 21 CFR 868.1505 | 6 |
| QRG | Ultrasound Guided Nerve Block Assist | 第 2 类 | 21 CFR 868.1980 | 3 |
| QVC | Ventilator Waveform Analysis Software | 第 2 类 | 21 CFR 868.5896 | 1 |
| QVE | Adjunctive Pain Measurement Device For Anesthesiology | 第 2 类 | 21 CFR 868.2200 | 1 |
| QVT | Monitor For Opioid Induced Impairment Of Oxygenation | 第 2 类 | 21 CFR 868.2250 | 1 |
| QWE | Hyperoxia Monitoring Device Adjunct To Pulse Oximetry | 第 2 类 | 21 CFR 870.2720 | 1 |
| QXD | Spinal Imaging System For Neuraxial Procedures | 第 2 类 | 21 CFR 868.1985 | 1 |
| QZW | Over-The-Counter Device To Assess Risk Of Sleep Apnea | 第 2 类 | 21 CFR 868.2378 | 3 |
| SDB | Tracheal Prosthesis With Cover Material Derived From Human Sources | 第 2 类 | 21 CFR 868.3721 | 1 |
| SDS | Compression-Based Airway Clearance Device | 第 2 类 | 21 CFR 868.5665 | |
| SDT | Intra-Pulmonary Percussive Vibration (Ipv) Devices | 第 2 类 | 21 CFR 868.5665 | 3 |
| SFP | Ventilator-Compatible Nebulizer | 第 2 类 | 21 CFR 868.5630 | 2 |
| SGR | Noninvasive Positive Airway Pressure System, Facility Use | 第 2 类 | 21 CFR 868.5895 | 2 |