510(k) K081330 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
| Applicant | O-Two Medical Technologies, Inc., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Mar 6, 2009 |
| Received | May 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081330
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.