510(k) Report

Devices descending from K951371

42 later devices reach 1481 T Digital Telemetry System with S-T Segment Analysis Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974492Siemens SC6000/SC6000P Bedside Monitoring System Enhanced with ST Segment AnalysisSiemens Medical Solutions USA, Inc.19980—
+1K972714Siemens Multiview Workstation Infinity Telemetry SystemSiemens Medical Solutions USA, Inc.199737—
+1K970920Siemens SC9000/SC9015 Bedside Monitoring SystemSiemens Medical Solutions USA, Inc.19972—
+2K032051Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649PAccess Battery, Inc.20041—
+2K024108Siemens Multi View Infinity Telemetry SystemSiemens Medical Solutions USA, Inc.200235—
+2K983980Siemens Multiview Infinity Telemetry System Enhancement, Additional Arrhythmia CallsSiemens Medical Solutions USA, Inc.199836—
+3K071164Life+Cel BatteryAmco International Manufacturing & Design, Inc.20070—
+3K061379Infinity Telesmart Telemetry SystemDraeger Medical Systems, Inc.200726—
+3K030738Siemens Multiview Infinity Telemetry SystemSiemens Medical Solutions USA, Inc.20037—
+4K130711Infinity Centralstation with Infinity M300Draeger Medical Systems, Inc.2013252
+4K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+4K06030712 RL AlgorithmGe Medical Systems Information Technologies20065—
+4K033305Infinity Multiview Infinity Telemetry SystemDraeger Medical Systems, Inc.20030—
+5K200859Infinity M300Draeger Medical Systems, Inc.202021
+5K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+5K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+5K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+5K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+5K151860Infinity CentralStation WideDraeger Medical Systems, Inc.2015232
+6K231477Infinity CentralStation Wide, Infinity M300, Infinity M300+Draeger Medical Systems, Inc.20231—
+6K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+6K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+7K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+7K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+8K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+8K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+9K241397HinscopeHinlab Sas20240—
+9K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+9K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+9K222550Current Health SystemCurrent Health, Ltd.20221—
+9K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+10K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+10K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+10K232915EpiMonitorEmpatica S.r.l.20241—
+10K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+10K231506Current Health SystemCurrent Health, Ltd.20230—
+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—