510(k) Report

Devices descending from K133806

3 later devices reach M1 Capnography Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172365Panoramic Oxygen Mask (POM)Pom Medical, LLC20182—
+2K222511Oxy2ProSouthmedic, Inc.20230—
+2K220533Endoscopy Oxygen MaskEngineered Medical Systems, Inc.20220—