510(k) Report

Devices descending from K981066

2 later devices reach Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel Electrocardiograph through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173226CardiMax ElectrocardiographFukuda Denshi USA, Inc.20180—
+1K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—