510(k) Report

Devices descending from K092043

4 later devices reach Bipap Synchrony 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+1K103395Performax Total Face MaskRespironics, Inc.20110—
+1K101130Bipap Synchrony 2 with AF531 Full Face MaskRespironics, Inc.20101—
+2K150639AF541 EE Full Face MaskRespironics, Inc.20150—