510(k) K912620 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
OPOMAT MANUAL RESUSCITATOR VENTILATOR
| Applicant | Euro-Am Pharma, Inc., Fanwood NJ, US |
| Decision | Substantially Equivalent, Dec 4, 1991 |
| Received | Jun 13, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912620
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.