510(k) Report

Devices descending from K013427

407 later devices reach Modification to:Philips M3000A/M3046A Compact Portable Patient Monitor, Models… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—