510(k) K912203 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
EMS SINGLE USE MANUAL RESUSCITATORS
| Applicant | Engineered Medical Systems, Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 13, 1991 |
| Received | May 20, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912203
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.