510(k) Report

Devices descending from K002544

148 later devices reach Medilog Excel 2 - Holter Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K210822DeepRhythmAIMedicalgorithmics S.A.20226—
+7K220095ANNE SleepSibel, Inc.20224—
+7K213007Cerebra Sleep SystemCerebra Medical, Ltd.20220—
+7K220028NightOwlEctosense NV20222—
+7K200705Nurochek SystemCryptych Pty, Ltd.20200—
+7K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc.20194—
+7K182227Esprit NovaNeurozone Msh Incorporated20190—
+7K172735WR19 SystemZeto, Inc.20183—
+7K170138NeuronauteBioserenity20170—
+7K162627EnsoSleepEnsodata, Inc.20179—
+7K141316Cognision Eeg/EP SystemNeuronetrix Solutions20157—
+8K254255S-Patch CardioAIWellysis Corp.20260—
+8K260455New Wave SystemZeto, Inc.20260—
+8K253668Onera SleepMap (SLEEPMAP)Onera B.V.20260—
+8K250460WatchPAT400 (WP400)Itamar Medical, Ltd.20251—
+8K243603AeviceMDAevice Health Pte., Ltd.20250—
+8K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC20250—
+8K243268TipTraQ (TTQ001)Pranaq Pte., Ltd.20250—
+8K241197DeepRhythmAIMedicalgorithmics S.A.20243—
+8K233755HeartKey® RhythmB-Secur Limited20240—
+8K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical20243—
+8K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd.20231—
+8K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—
+8K221179SomnoMetryNeumetry Medical, Inc.20223—
+8K220056iSyncWaveiMediSync, Inc.20220—
+8K213900WAVi SCAN EEG System and AccessoriesWavi Co.20220—
+8K210034EnsoSleepEnsodata, Inc.20210—
+8K202527Zio ECG Utilization Software (ZEUS) SystemiRhythm Technologies, Inc.20213—
+8K192753NeuralScan SystemMedeia, Inc.20203—
+8K171781eVox SystemEvoke Neuroscience, Inc.20176—
+9K254042WatchPAT SWItamar Medical, Ltd.20260—
+9K253767UB ERP SystemUniversal Brain20260—
+9K253390Somnum (Somnum)Honeynaps Co., Ltd.20260—
+9K250932DeepRhythmAIMedicalgorithmics S.A.20251—
+9K242129VitalRhythmVitalconnect, Inc.20250—
+9K244027Sansa HsatHuxley Medical20252—
+9K241288Noxturnal WebNox Medical Ehf20242—
+9K240420NeuroField Analysis SuiteNeurofield, Inc.20240—
+9K221959Q21Neurofield, Inc.20230—
+9K221963Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited20231—
+9K222389ZEUS SystemiRhythm Technologies, Inc.20231—
+9K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+10K261747Report StudioBeacon Biosignals, Inc.20260—
+10K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express20260—
+10K252859ZEUS Platform (FG0501US)iRhythm Technologies, Inc.20260—
+10K260585Noxturnal WebNox Medical Ehf20260—
+10K253141DeepRhythmAIMedicalgorithmics S.A.20250—
+10K252497Sansa HsatHuxley Medical20250—