510(k) K984407 ยท MNS Ventilator, Continuous, Non-Life-Supporting
BIPAP HARMONY S/T, MODEL 1001445
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, May 19, 1999 |
| Received | Dec 9, 1998 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K984407
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.