510(k) Report

Devices descending from K113485

3 later devices reach Electrocardiograph through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180432AI-ECG PlatformShenzhen Carewell Electronics., Ltd.20180—
+1K131900Contec ElectrocardiographContec Medical System Co., Ltd.20141—
+2K171360CONTEC™ ElectrocardiographContec Medical Systems Co.,Ltd20180—