510(k) Report

Devices descending from K063806

6 later devices reach Sleepnet Mojo -NV Full Face Mask, Non-Vented through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full…Sleepnet Corporation20191Class I
+1K102317IQ Ventilation Nasal MaskSleepnet Corporation20112—
+1K081743Classicstar NV SE and Novastar NV SE and Aav Full Face MasksDraeger Medical AG & Co. KG20080Class I
+2K241520Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full…Sleepnet Corporation20240—
+2K203601Innova Nasal Non-Vented MaskSleepnet Corporation20210—
+2K121321Hard Shell Vented Nasal MaskSleepnet Corporation20120—