510(k) Report

Devices descending from K083122

4 later devices reach Hospital Full Face Mask Non Vented, Model: RT041 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173060F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow VersionFisher and Paykel Healthcare Limited20182—
+1K102120Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model…Hsiner Co., Ltd.20110—
+2K203449F&P Visairo NIV Mask RangeFisher & Paykel Healthcare, Ltd.20211—
+3K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A…Fisher & Paykel Healthcare, Ltd.20250—