510(k) K023670 ยท BZD Ventilator, Non-Continuous (Respirator)
SINGLE USE ORAL MASK, MODEL HC455A
| Applicant | Fisher & Paykel Healthcare, Ltd., East Tamaki, Auckland, NZ |
| Decision | Substantially Equivalent, Jun 12, 2003 |
| Received | Oct 31, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023670
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.