510(k) K963848 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
MANUAL RESUSCITATOR
| Applicant | Owens-Brigam Medical Co., Newland NC, US |
| Decision | Substantially Equivalent, Jul 7, 1997 |
| Received | Sep 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963848
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.