510(k) Report

Devices descending from K121912

4 later devices reach E1 Ear Sensors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133—
+2K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+3K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+4K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—