510(k) K972605 ยท BZD Ventilator, Non-Continuous (Respirator)
EMS NASAL CPAP MASK
| Applicant | Engineered Medical Systems, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 28, 1998 |
| Received | Jul 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972605
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.