510(k) K023683 ยท BZD Ventilator, Non-Continuous (Respirator)
MULTI-STRAP FULL FACE MASK
| Applicant | Engineered Medical Systems, Mccordsville IN, US |
| Decision | Substantially Equivalent, Dec 1, 2003 |
| Received | Nov 1, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023683
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.