510(k) K922810 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
ODYSSEY
| Applicant | O-Two Systems Intl., Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Jan 22, 1993 |
| Received | Jun 10, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922810
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.