510(k) K980551 ยท BZD Ventilator, Non-Continuous (Respirator)
SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
| Applicant | Nidek Medical Products, Inc., Birmingham AL, US |
| Decision | Substantially Equivalent, Nov 17, 1998 |
| Received | Feb 12, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980551
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.