510(k) Report

Devices descending from K062019

8 later devices reach Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBD through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+1K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation20076Class I
+2K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full…Sleepnet Corporation20191Class I
+2K102317IQ Ventilation Nasal MaskSleepnet Corporation20112—
+2K081743Classicstar NV SE and Novastar NV SE and Aav Full Face MasksDraeger Medical AG & Co. KG20080Class I
+3K241520Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full…Sleepnet Corporation20240—
+3K203601Innova Nasal Non-Vented MaskSleepnet Corporation20210—
+3K121321Hard Shell Vented Nasal MaskSleepnet Corporation20120—