510(k) Report

Devices descending from K030515

11 later devices reach Hans Rudolph 7500 Series Reusable Oro-Nasal Niv Masks through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071149Hri 6500, 6600 and 6700 Series V2MASKSHans Rudolph, Inc.20081—
+1K062019Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBDInnomed Technologies, Inc./Respcare, Inc.20068—
+2K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+2K143603Darlinghurst Vented, Darlinghurst NV-AAVResmed, Ltd.20150—
+2K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation20076Class I
+3K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full…Sleepnet Corporation20191Class I
+3K102317IQ Ventilation Nasal MaskSleepnet Corporation20112—
+3K081743Classicstar NV SE and Novastar NV SE and Aav Full Face MasksDraeger Medical AG & Co. KG20080Class I
+4K241520Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full…Sleepnet Corporation20240—
+4K203601Innova Nasal Non-Vented MaskSleepnet Corporation20210—
+4K121321Hard Shell Vented Nasal MaskSleepnet Corporation20120—