510(k) K904396 ยท BZQ Monitor, Breathing Frequency
SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM
| Applicant | Simplex Medical Systems, Inc., Las Vegas NV, US |
| Decision | Substantially Equivalent, Mar 5, 1991 |
| Received | Sep 25, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904396
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.