510(k) Report

Devices descending from K203449

1 later device reach F&P Visairo NIV Mask Range through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A…Fisher & Paykel Healthcare, Ltd.20250—