510(k) K083050 ยท CBK Ventilator, Continuous, Facility Use
EVITE XL
| Applicant | Draeger Medical AG & Co. KG, Telford PA, US |
| Decision | Substantially Equivalent, Dec 29, 2008 |
| Received | Oct 14, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083050
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.