510(k) K780216 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
LIFESAVER, MANUAL #5160
| Applicant | Hudson Oxygen Therapy Sales Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 14, 1978 |
| Received | Feb 10, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K780216
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.