510(k) K032386 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
| Applicant | Impact Instrumentation, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, Mar 26, 2004 |
| Received | Aug 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032386
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.