510(k) K932797 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
PRESSURE LIMITING ELBOW
| Applicant | Engineered Medical Systems, Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 3, 1993 |
| Received | Jun 9, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932797
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.