510(k) K092085 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
ISPIRA RESUSCITATION UNIT
| Applicant | Neoforce Group, Inc., Ivyland PA, US |
| Decision | Substantially Equivalent, Oct 7, 2009 |
| Received | Jul 9, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092085
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.