510(k) K021446 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR
| Applicant | Oemedic International, Inc., Littleton CO, US |
| Decision | Substantially Equivalent, Oct 11, 2002 |
| Received | May 6, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021446
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.