510(k) Report

Devices descending from K130328

2 later devices reach F&P Simplus Full Face Mask through their predicates, nearest generation first.

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