510(k) K944349 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
OXYLATOR EM-100
| Applicant | Cpr Medical Devices, Inc., North Attleboro MA, US |
| Decision | Substantially Equivalent, Apr 17, 1995 |
| Received | Sep 6, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944349
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.