510(k) K900577 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT)
| Applicant | Intertech Resources, Inc., Fort Myers FL, US |
| Decision | Substantially Equivalent, Jul 16, 1990 |
| Received | Feb 7, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900577
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.