510(k) Report

Devices descending from K002837

307 later devices reach Bis Engine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+14K231506Current Health SystemCurrent Health, Ltd.20230—
+15K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+15K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+15K252981EmbraceMiniEmpatica S.r.l.20251—
+15K250515EpiMonitorEmpatica S.r.l.20250—
+15K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+15K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—