510(k) Report

Devices descending from K030267

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K250515EpiMonitorEmpatica S.r.l.20250—
+11K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+11K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—