510(k) K761065 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
NEONATAL RESUSCITATOR, SAMSON
| Applicant | Dem Medical, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Jan 26, 1977 |
| Received | Nov 18, 1976 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K761065
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.