510(k) Report

Devices descending from K882609

504 later devices reach Models M1175A & M1176A Component Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+11K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+11K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+12K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—