510(k) K051263 ยท CBK Ventilator, Continuous, Facility Use
EVITAXL WITH OPTION SMARTCARE
| Applicant | Drager Medical AG & Co. Kgaa, Telford PA, US |
| Decision | Substantially Equivalent, Jul 12, 2005 |
| Received | May 16, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051263
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2008 | Draeger Medical, Inc. Evita XL Critical Care Ventilator. Continuous (Respirator) Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.