510(k) Report

Devices descending from K021534

5 later devices reach IQ Nasal Mask, Model 50160 Rev. D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211274iQ 2 Nasal Mask, Phantom 2 Nasal MaskSleepnet Corporation20221Class I
+1K102317IQ Ventilation Nasal MaskSleepnet Corporation20112—
+2K241469iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented MaskSleepnet Corporation20240—
+2K203601Innova Nasal Non-Vented MaskSleepnet Corporation20210—
+2K121321Hard Shell Vented Nasal MaskSleepnet Corporation20120—