510(k) K970165 ยท CBK Ventilator, Continuous, Facility Use
EVITA 2 DURA
| Applicant | Drager, Inc., Chantilly VA, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Aug 26, 1997 |
| Received | Jan 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970165
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.