510(k) K252173 · CBK Ventilator, Continuous, Facility Use
F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C
| Applicant | Fisher & Paykel Healthcare, Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Sep 10, 2025 |
| Received | Jul 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252173
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.