510(k) Report

Devices descending from K061736

2 later devices reach Comfort Flo Humidification System and Nasal Cannula through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131912Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart…Teleflex, Inc.20141Class I
+2K162242Comfort Flo Humidification SystemTeleflexmedical, Inc.20170Class I