510(k) Report

Devices descending from K121597

4 later devices reach Eson Nasal Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited20160—
+1K130328F&P Simplus Full Face MaskFisher & Paykel Healthcare Limited20132—
+2K190713F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face…Fisher & Paykel Healthcare, Ltd.20191—
+3K212371F&P Evora Full Face MaskFisher & Paykel Healthcare, Ltd.20220—