510(k) Report

Devices descending from K012832

2 later devices reach Comfortmate Fluid Warming System, Model # FW-200; Comfortmate Disporsable… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071263Nxstage Travel Warmer, Models TW-400 & FWS-500Nxstage Medical, Inc.200711
+2K140623Nxstage Express Fluid WarmerNxstage Medical, Inc.20140—