510(k) K943617 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
DISPOSABLE MANUAL RESUSCITATOR
| Applicant | Puritan-Bennett, Lenexa KS, US |
| Decision | Substantially Equivalent, Aug 11, 1994 |
| Received | Jul 27, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943617
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.