510(k) K000888 ยท BZD Ventilator, Non-Continuous (Respirator)
SANSIBAR CPAP SYSTEM
| Applicant | Prym Medical , Ltd., Ra'Ananna 43373, IL |
| Decision | Substantially Equivalent, Aug 15, 2000 |
| Received | Mar 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000888
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.