510(k) Report

Devices descending from K061379

26 later devices reach Infinity Telesmart Telemetry System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130711Infinity Centralstation with Infinity M300Draeger Medical Systems, Inc.2013252
+2K200859Infinity M300Draeger Medical Systems, Inc.202021
+2K151860Infinity CentralStation WideDraeger Medical Systems, Inc.2015232
+3K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+3K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+3K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+4K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+4K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+5K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+5K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+6K241397HinscopeHinlab Sas20240—
+6K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+6K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+6K222550Current Health SystemCurrent Health, Ltd.20221—
+6K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+7K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+7K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+7K232915EpiMonitorEmpatica S.r.l.20241—
+7K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+7K231506Current Health SystemCurrent Health, Ltd.20230—
+8K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+8K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+8K252981EmbraceMiniEmpatica S.r.l.20251—
+8K250515EpiMonitorEmpatica S.r.l.20250—
+8K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+8K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—