510(k) Report

Devices descending from K013199

431 later devices reach Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+9K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+9K232915EpiMonitorEmpatica S.r.l.20241—
+9K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+9K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+9K231506Current Health SystemCurrent Health, Ltd.20230—
+9K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+9K213515WesperO2Wesper, Inc.20220—
+9K202851Spo2 SensorJkh USA, LLC20201—
+9K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+9K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+9K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+9K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+9K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+9K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+9K173045OximeterShenzhen Greatmade Tech Limited20180—
+9K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+10K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+10K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+10K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+10K252981EmbraceMiniEmpatica S.r.l.20251—
+10K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+10K250515EpiMonitorEmpatica S.r.l.20250—
+10K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+10K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+10K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+10K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+10K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+10K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+10K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+11K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—