510(k) K010704 ยท BZD Ventilator, Non-Continuous (Respirator)
DORNIR LC-1 CPAP SYSTEM
| Applicant | Prym Medical , Ltd., Ra'Ananna 43373, IL |
| Decision | Substantially Equivalent, Apr 18, 2001 |
| Received | Mar 9, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010704
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.