510(k) K834400 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
FLYNN III-CHILD BAG-MASK UNIT ETC
| Applicant | O-Two Systems Intl., Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 13, 1984 |
| Received | Dec 14, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K834400
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.