510(k) K832495 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
FLYNN SERIES III BAG/MASK UNIT-
| Applicant | O-Two Systems Intl., Inc., Walker MI, US |
| Decision | Substantially Equivalent, Sep 29, 1983 |
| Received | Jul 27, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K832495
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.