510(k) K913039 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
FLLYNN(R) GENESIS AC
| Applicant | O-Two Systems Intl., Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Aug 25, 1992 |
| Received | Jul 9, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913039
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.