510(k) K943207 ยท BZD Ventilator, Non-Continuous (Respirator)
NITELIFE BI-LEVEL CPAP
| Applicant | Airsep Corp., Buffalo NY, US |
| Decision | Substantially Equivalent, Jul 29, 1996 |
| Received | Jul 5, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943207
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.