510(k) K060705 ยท CBK Ventilator, Continuous, Facility Use
CARINA HOME
| Applicant | Draeger Medical B.V., Telford PA, US |
| Decision | Substantially Equivalent, Jun 14, 2006 |
| Received | Mar 16, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060705
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2009 | Draeger Medical, Inc. Carina Home Ventilator.
The device is used as a continuous respirator/ventilator for home use. Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.