510(k) Report

Devices descending from K162627

9 later devices reach EnsoSleep through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253668Onera SleepMap (SLEEPMAP)Onera B.V.20260—
+1K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC20250—
+1K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd.20231—
+1K221179SomnoMetryNeumetry Medical, Inc.20223—
+1K210034EnsoSleepEnsodata, Inc.20210—
+2K253390Somnum (Somnum)Honeynaps Co., Ltd.20260—
+2K241288Noxturnal WebNox Medical Ehf20242—
+3K261747Report StudioBeacon Biosignals, Inc.20260—
+3K260585Noxturnal WebNox Medical Ehf20260—