510(k) K964653 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
OASIS HUMIDIFIER
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Feb 14, 1997 |
| Received | Nov 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964653
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.