510(k) Report

Devices descending from K865032

3 later devices reach Cardiofax-V Ecg-834OA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972310Nihon Kohden QP-932E Ecg Exercise Test Option for the Nihon Kohden Ecg-9320/a Cardiofax…Nihon Kohden America, Inc.19971—
+1K961272Nihon Kohden Ecg-9320A Cardiofax and AccessoriesNihon Kohden America, Inc.19960—
+2K072060QP-156E Ecg Exercise Test Option for the Ecg-1500A Series/Cardiofax VNihon Kohden America, Inc.20070—