BZR
- Product code
- BZR
- Device name
- Mixer, Breathing Gases, Anesthesia Inhalation
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5330
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 55
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243917 | 2025-07-14 | Fisher & Paykel Healthcare, Ltd. | F&P Optiflow Air/Oxygen Flow Source | |
| K241465 | 2024-09-19 | Parker Hannifin Corporation | Midas Flowmeter; eAVS | |
| K231895 | 2023-12-04 | Maxtec, LLC | Maxtec MaxBlend2+p | |
| K230987 | 2023-09-14 | Baldus Sedation GmbH & Co. KG | FlowStar Analog Mixer Flowmeter |
Official FDA classification page: BZR
Classification and pathway per current FDA publications. Data from openFDA (CC0).