510(k) K081743 ยท CBK Ventilator, Continuous, Facility Use
CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS
| Applicant | Draeger Medical AG & Co. KG, Luebeck, DE |
| Decision | Substantially Equivalent, Sep 22, 2008 |
| Received | Jun 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081743
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2023 | Draeger Medical, Inc. NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L) Open, Classified |
CBK | None listed |
| Feb 24, 2023 | Draeger Medical, Inc. NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L) Open, Classified |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.