510(k) K911298 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
PRESSURE LIMITING ELBOW WITH MANOMETER PORT
| Applicant | Intertech Resources, Inc., Fort Myers FL, US |
| Decision | Substantially Equivalent, Jun 25, 1991 |
| Received | Mar 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911298
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.