510(k) K964363 ยท BZD Ventilator, Non-Continuous (Respirator)
BIPAP DUET SYSTEM
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Jan 30, 1997 |
| Received | Nov 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964363
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.