510(k) K051476 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
UNI-VENT MODEL 73X
| Applicant | Impact Instrumentation, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, Oct 28, 2005 |
| Received | Jun 3, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051476
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2011 | Impact Instrumentation, Inc. Model 73X Uni-Vent
Product Usage: Intended for use at mass casualty incidents. Terminated |
BTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.