510(k) Report

Devices descending from K003154

116 later devices reach Mizar, Basis BE, Sandman Digital through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+8K210034EnsoSleepEnsodata, Inc.20210—
+8K192753NeuralScan SystemMedeia, Inc.20203—
+8K171781eVox SystemEvoke Neuroscience, Inc.20176—
+9K254042WatchPAT SWItamar Medical, Ltd.20260—
+9K253767UB ERP SystemUniversal Brain20260—
+9K253390Somnum (Somnum)Honeynaps Co., Ltd.20260—
+9K244027Sansa HsatHuxley Medical20252—
+9K241288Noxturnal WebNox Medical Ehf20242—
+9K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+9K221959Q21Neurofield, Inc.20230—
+9K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—
+10K261747Report StudioBeacon Biosignals, Inc.20260—
+10K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express20260—
+10K260585Noxturnal WebNox Medical Ehf20260—
+10K252497Sansa HsatHuxley Medical20250—