510(k) Report

Devices descending from K062605

46 later devices reach Philips SPO2 Reusable Sensor, Models M1196A and M1196T through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m)…Philips Medizin Systeme Böblingen GmbH20260—
+1K243086Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable…Unimed Medical Supplies, Inc.20250—
+1K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+1K090438Reusable Envitec Finger SPO2 Sensor-HP/Philips Compatible, Models F-2412, F-2414-15…Envitec-Wismar GmbH20090—
+1K063783Philips Reusable SPO2 Sensors M1191T, M1192T and M1193T, Clip Sensor M1196T and…Philips Medical Systems, Inc.200741—
+2K092549Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600PBio Medical Technologies Co., Ltd.20091—
+2K091572Disposable SPO2 Sensor M1134APhilips Medizinsysteme Boeblingen GmbH, Cardiac AN200938—
+3K132516Oxiprobe E (Oxiprobe)Bio Medical Technologies Co., Ltd.20140—
+3K101600Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216, Intellivue…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201037—
+4K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+4K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+5K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+6K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+6K220111RespiraSensePmd Solutions20221—
+6K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+6K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+6K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+7K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+7K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+7K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+7K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+7K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+8K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+8K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+8K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+8K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH20182—
+9K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+9K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+9K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+9K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+10K241397HinscopeHinlab Sas20240—
+10K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+10K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+10K222550Current Health SystemCurrent Health, Ltd.20221—
+10K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+11K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+11K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+11K232915EpiMonitorEmpatica S.r.l.20241—
+11K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+11K231506Current Health SystemCurrent Health, Ltd.20230—
+12K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+12K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+12K252981EmbraceMiniEmpatica S.r.l.20251—
+12K250515EpiMonitorEmpatica S.r.l.20250—
+12K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+12K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—