510(k) K093081 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
POCKET BVM
| Applicant | Microbvm Systems , Ltd., Efrat, IL |
| Decision | Substantially Equivalent, Feb 5, 2010 |
| Received | Oct 1, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093081
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.