510(k) Report

Devices descending from K023871

406 later devices reach M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—