510(k) Report

Devices descending from K953107

2 later devices reach Anesthesia/Respiratory Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163277SuperNO2VA DeviceRevolutionary Medical Devices, Inc.20171—
+2K173147SuperNO2VA Et DeviceRevolutionary Medical Devices, Inc.20180—