510(k) K863377 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
MR338 SERVO HEATED DELIVERY HUMIDIFIER
| Applicant | Fisher & Paykel Allied Products , Ltd., Auckland, New Zealand, NZ |
| Decision | Substantially Equivalent, Feb 20, 1987 |
| Received | Sep 3, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863377
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.