510(k) Report

Devices descending from K923043

307 later devices reach Spectral Eeg Monitor Model A1000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K231506Current Health SystemCurrent Health, Ltd.20230—
+14K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+14K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+14K252981EmbraceMiniEmpatica S.r.l.20251—
+14K250515EpiMonitorEmpatica S.r.l.20250—
+14K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+14K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—