510(k) Report

Devices descending from K101876

13 later devices reach Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010, Ecg-6010 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131858Digital ElectrocardiographGuangdong Biolight Meditech Co., Ltd.20140—
+1K122712Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd.20128—
+1K113485ElectrocardiographShenzhen Carewell Electronics Co., Ltd.20123—
+1K112431Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd.20119—
+2K233266Mediblu Ecg SystemMediblu Medical, LLC20240—
+2K180432AI-ECG PlatformShenzhen Carewell Electronics., Ltd.20180—
+2K131900Contec ElectrocardiographContec Medical System Co., Ltd.20141—
+2K132758Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20141—
+2K131262Digital ElectrocardiographsSonoscape Company Limited20130—
+2K123816Digital ElectrocardiographsShenzhen Biocare Electronics Co., Ltd.20134—
+3K171360CONTEC™ ElectrocardiographContec Medical Systems Co.,Ltd20180—
+3K133985Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20151—
+4K152384Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20150—