510(k) K991955 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
| Applicant | Engineered Medical Systems, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 6, 1999 |
| Received | Jun 1, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991955
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.