510(k) Report

Devices descending from K200089

5 later devices reach F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243583F&P Nova Nasal MaskFisher & Paykel Healthcare Limited20250—
+1K233415DELTAWAVE Nasal Pillows SystemRemsleep Holdings20241—
+1K223696F&P Solo Mask RangeFisher & Paykel Healthcare, Ltd.20231—
+2K253939DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc.20260—
+2K233829Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model…Fisher and Paykel Healthcare Limited20240—