510(k) K895946 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
BIVONA CARDEN INTERMITTENT JETTING DEVICE
| Applicant | Bivona Medical Technologies, Gary IN, US |
| Decision | Substantially Equivalent, Jan 9, 1990 |
| Received | Oct 11, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895946
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.