510(k) Report

Devices descending from K963644

340 later devices reach A-1000 Eeg Monitor and a-1050 Eeg Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K223905Vivio® LVEDP SystemAvicena, LLC20230—
+12K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+12K231335Cleerly ISCHEMIACleerly, Inc.20230—
+12K221203AHI SystemFifth Eye, Inc.20220—
+12K212227Philips MR Patient Care PortalInvivo Corporation202101
+12K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+12K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+12K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+12K192595ExSpiron 2XiRespiratory Motion20190—
+12K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+12K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+12K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+12K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+12K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+13K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+13K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+13K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+13K254066Etiometry PlatformEtiometry, Inc.20260—
+13K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+13K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+13K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—
+13K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+13K241397HinscopeHinlab Sas20240—
+13K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+13K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+13K222550Current Health SystemCurrent Health, Ltd.20221—
+13K212271smart-syncNorthh Medical GmbH20220—
+13K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+13K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+14K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+14K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+14K232915EpiMonitorEmpatica S.r.l.20241—
+14K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+14K231506Current Health SystemCurrent Health, Ltd.20230—
+15K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+15K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+15K252981EmbraceMiniEmpatica S.r.l.20251—
+15K250515EpiMonitorEmpatica S.r.l.20250—
+15K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+15K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—