510(k) K010093 ยท CBK Ventilator, Continuous, Facility Use
NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
| Applicant | Drager Medizintechnik GmbH, Telford PA, US |
| Decision | Substantially Equivalent, Jun 14, 2001 |
| Received | Jan 11, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010093
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2008 | Draeger Medical, Inc. Evita 2 dura Critical Care Ventilator. Continuous (Respirator) Terminated |
CBK | None listed |
| Sep 20, 2008 | Draeger Medical, Inc. Evita 4 Critical Care Ventilator. Continuous (Respirator) Terminated |
CBK | None listed |
| Jun 27, 2003 | Draeger Medical, Inc. Evita 4 Continuous Ventilator Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.