510(k) Report

Devices descending from K011534

316 later devices reach Eeg Mis Monitor Model # a-2000; Bis Engine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+10K222550Current Health SystemCurrent Health, Ltd.20221—
+10K212271smart-syncNorthh Medical GmbH20220—
+10K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+10K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+11K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+11K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+11K232915EpiMonitorEmpatica S.r.l.20241—
+11K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+11K231506Current Health SystemCurrent Health, Ltd.20230—
+12K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+12K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+12K252981EmbraceMiniEmpatica S.r.l.20251—
+12K250515EpiMonitorEmpatica S.r.l.20250—
+12K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+12K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—