510(k) K880394 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR
| Applicant | Intertech/Ohio, Fort Myers FL, US |
| Decision | Substantially Equivalent, Feb 29, 1988 |
| Received | Jan 29, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880394
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.