510(k) Report

Devices descending from K143216

2 later devices reach Assurance Alar / Nasal SpO2 Sensor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+2K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—