510(k) K911971 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT.
| Applicant | Puritan Bennett Corp., Overland Park KS, US |
| Decision | Substantially Equivalent, Aug 9, 1991 |
| Received | May 3, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911971
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.