510(k) K971243 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
OHMEDA INFANT RESUSCITATION SYSTEM
| Applicant | Ohmeda Medical, Columbia MD, US |
| Decision | Substantially Equivalent, Dec 2, 1997 |
| Received | Apr 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971243
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.