510(k) Report

Devices descending from K031694

304 later devices reach Modification to Eeg Monitor with Bis, Model a-2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—