510(k) K973161 ยท BZD Ventilator, Non-Continuous (Respirator)
CPAP HUMIDIFIER (HC 200)
| Applicant | Fisher & Paykel Electronics , Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Jul 10, 1998 |
| Received | Aug 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973161
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.