510(k) Report

Devices descending from K023068

3 later devices reach Papillon Mask Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082866Revolutionfull Face MaskRespironics Inc., Sleep & Home Respiratory Group20092Class I
+2K140580Revolution Fullface MaskRespironics Inc. (Dba Philips Respironics)20150—
+2K142554Revolution Full Face MaskRespironics, Inc.20150Class I