510(k) K894365 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR
| Applicant | Puritan Bennett Corp., Overland Park KS, US |
| Decision | Substantially Equivalent, Oct 6, 1989 |
| Received | Jul 14, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894365
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.