510(k) K082092 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE
| Applicant | Galemed Corp., Carlsbad CA, US |
| Decision | Substantially Equivalent, Oct 15, 2008 |
| Received | Jul 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082092
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.