510(k) Report

Devices descending from K030822

3 later devices reach 7600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/NPPV Masks through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071149Hri 6500, 6600 and 6700 Series V2MASKSHans Rudolph, Inc.20081—
+1K052249UtopiaRespcare, Inc.20050—
+2K143603Darlinghurst Vented, Darlinghurst NV-AAVResmed, Ltd.20150—