510(k) Report

Devices descending from K962424

310 later devices reach NPB-4000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K231506Current Health SystemCurrent Health, Ltd.20230—
+10K212271smart-syncNorthh Medical GmbH20220—
+10K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+10K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+11K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+11K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+11K252981EmbraceMiniEmpatica S.r.l.20251—
+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—