510(k) Report

Devices descending from K001359

302 later devices reach Dash 3000/4000 Patient Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+14K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+14K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—