510(k) Report

Devices descending from K973161

110 later devices reach Cpap Humidifier (HC 200) 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—
+8K234058F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)Fisher & Paykel Healthcare, Ltd.20241—
+8K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd.20240—
+8K213169BPAP SystemBMC Medical Co., Ltd.20220—
+8K212371F&P Evora Full Face MaskFisher & Paykel Healthcare, Ltd.20220—
+8K161492Juno VPAP ST-AResmed, Ltd.20171—
+9K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+9K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.20250—
+9K250624myAirResmed Corp20251—
+10K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—