510(k) K850647 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
HEATED RESPIRATORY HUMIFIFIER MR440
| Applicant | Fisher & Paykel Allied Products , Ltd., Auckland, New Zealand, NZ |
| Decision | Substantially Equivalent, Mar 12, 1985 |
| Received | Feb 19, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850647
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.