510(k) K953392 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)
| Applicant | Fisher & Paykel Electronics , Ltd., Auckland, New Zealand, NZ |
| Decision | Substantially Equivalent, Mar 12, 1996 |
| Received | Jul 19, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953392
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.