510(k) Report

Devices descending from K012466

305 later devices reach Bis/Eeg Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+13K252981EmbraceMiniEmpatica S.r.l.20251—
+13K250515EpiMonitorEmpatica S.r.l.20250—
+13K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+13K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—