510(k) Report

Devices descending from K091927

124 later devices reach Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+6K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+6K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+6K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+7K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+7K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+7K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+7K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+7K241397HinscopeHinlab Sas20240—
+7K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+7K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+7K222550Current Health SystemCurrent Health, Ltd.20221—
+7K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+8K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+8K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+8K232915EpiMonitorEmpatica S.r.l.20241—
+8K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+8K231506Current Health SystemCurrent Health, Ltd.20230—
+9K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+9K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+9K252981EmbraceMiniEmpatica S.r.l.20251—
+9K250515EpiMonitorEmpatica S.r.l.20250—
+9K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+9K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—