510(k) K212371 ยท BZD Ventilator, Non-Continuous (Respirator)
F&P Evora Full Face Mask
| Applicant | Fisher & Paykel Healthcare, Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Mar 18, 2022 |
| Received | Jul 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212371
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.