510(k) Report

Devices descending from K041362

2 later devices reach Resmed Hospital Full Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071149Hri 6500, 6600 and 6700 Series V2MASKSHans Rudolph, Inc.20081—
+2K143603Darlinghurst Vented, Darlinghurst NV-AAVResmed, Ltd.20150—