510(k) Report

Devices descending from K041963

3 later devices reach American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi and B9100, 6 Psi through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113542Salter Labs Bubble Humidifier (High Flow)Salter Labs, Arvin Facility20122—
+2K161719Salter Labs Bubble HumidifierSalter Labs20171—
+3K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI®…Medline Industries, Inc.20230—