510(k) K093862 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
CAREVENT HANDHELD CPAP SYSTEM
| Applicant | O-Two Medical Technologies, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, May 6, 2010 |
| Received | Dec 17, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093862
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.