CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS
FDA 510(k) clearance K081743 · decided 2008-09-22
Clearance details
- K-number
- K081743
- Device name
- CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS
- Applicant
- Draeger Medical AG & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 2008-06-19
- Decision date
- 2008-09-22
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Luebeck, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Si recall (Z-1137-2023) | Draeger Medical, Inc. | 2023-02-24 |
| NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M) recall (Z-1138-2023) | Draeger Medical, Inc. | 2023-02-24 |