510(k) Report

Devices descending from K922058

515 later devices reach Models M1175A and M1176A Component Monitoring Syst through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+10K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+10K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+10K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+10K173045OximeterShenzhen Greatmade Tech Limited20180—
+10K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+10K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+11K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+11K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+11K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+11K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+11K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+11K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—
+11K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+12K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—