510(k) K203449 ยท CBK Ventilator, Continuous, Facility Use
F&P Visairo NIV Mask Range
| Applicant | Fisher & Paykel Healthcare, Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Apr 14, 2021 |
| Received | Nov 23, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203449
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.