510(k) K000215 ยท BZD Ventilator, Non-Continuous (Respirator)
SWIVEL ELBOW
| Applicant | Engineered Medical Systems, Indianapolis IN, US |
| Decision | Substantially Equivalent, May 26, 2000 |
| Received | Jan 24, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000215
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.