510(k) Report

Devices descending from K974496

337 later devices reach A-2000 Eeg Monitor with Bis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K221203AHI SystemFifth Eye, Inc.20220—
+11K212227Philips MR Patient Care PortalInvivo Corporation202101
+11K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+11K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+11K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+11K192595ExSpiron 2XiRespiratory Motion20190—
+11K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+11K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+11K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx20180—
+11K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+11K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+12K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+12K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+12K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+12K254066Etiometry PlatformEtiometry, Inc.20260—
+12K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+12K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+12K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—
+12K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+12K241397HinscopeHinlab Sas20240—
+12K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+12K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+12K222550Current Health SystemCurrent Health, Ltd.20221—
+12K212271smart-syncNorthh Medical GmbH20220—
+12K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+12K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+13K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+13K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+13K232915EpiMonitorEmpatica S.r.l.20241—
+13K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+13K231506Current Health SystemCurrent Health, Ltd.20230—
+14K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+14K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+14K252981EmbraceMiniEmpatica S.r.l.20251—
+14K250515EpiMonitorEmpatica S.r.l.20250—
+14K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+14K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—