510(k) K915460 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
HEATED RESPIRATORY HUMIDIFIER HC100
| Applicant | Fisher & Paykel Electronics , Ltd., Auckland, New Zealand, NZ |
| Decision | Substantially Equivalent, Jan 15, 1993 |
| Received | Dec 4, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915460
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.