510(k) K905002 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
SINGLE USE MANUAL RESUSCITATORS
| Applicant | Custom Medical, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Mar 29, 1991 |
| Received | Nov 7, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905002
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.