510(k) Report

Devices descending from K123176

2 later devices reach Iso-Gard Clearair Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132729Iso-Gard MaskTeleflexmedical, Inc.20141—
+2K142138Iso-Gard MaskTeleflexmedical, Inc.20140—