510(k) Report

Devices descending from K900164

107 later devices reach Airway Delivery & Management (Adam) Nasal Ventila. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K233829Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model…Fisher and Paykel Healthcare Limited20240—
+8K212371F&P Evora Full Face MaskFisher & Paykel Healthcare, Ltd.20220—
+8K210844DreamWear Silicone Pillows MaskRespironics, Inc.20211—
+8K161978AirFit N20Resmed, Ltd.20165Class I
+9K171212AirFit N20Resmed, Ltd.20173Class I
+10K180497Scone MaskResmed, Ltd.20181—
+11K223747Whitsundays Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20230—