510(k) Report

Devices descending from K024322

113 later devices reach Embla N7000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—
+7K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+7K200565GalapogosResmed Corp20213—
+7K183226Care Orchestrator EssenceRespironics, Inc.20190—
+7K181053Care OrchestratorRespironics, Inc.20191—
+8K254042WatchPAT SWItamar Medical, Ltd.20260—
+8K244027Sansa HsatHuxley Medical20252—
+8K241216myAirResmed Corp20242—
+8K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.20200—
+9K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express20260—
+9K252497Sansa HsatHuxley Medical20250—
+9K250624myAirResmed Corp20251—
+10K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp20250—