510(k) Report

Devices descending from K091513

32 later devices reach Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171943ElectrocardiographEdan Instruments, Inc.20171—
+1K141946Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20153—
+1K123148Parace MD Ekoscope IS100Parace, LLC20130—
+1K130207Spacelabs Healthcare CardioexpressSpacelabs Healthcare, Ltd.20130—
+1K111805Ecg Series ElectrocardiographAdvanced Instrumentations, Inc.20110—
+1K101876Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010, Ecg-6010Shenzhen Biocare Electronics Co., Ltd.201113—
+1K102830ElectrocardiographEdan Instruments, Inc.20109—
+2K232816Electrocardiograph, model: ECG301Shenzhen LE Medical Technology Co., Ltd.20240—
+2K171517Digital ElectrocardiographBiocare Bio-Medical Equipment Co., Ltd.20180—
+2K160876PC ECGEdan Instruments, Inc.20178—
+2K160092Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20161—
+2K131858Digital ElectrocardiographGuangdong Biolight Meditech Co., Ltd.20140—
+2K122712Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd.20128—
+2K113485ElectrocardiographShenzhen Carewell Electronics Co., Ltd.20123—
+2K112431Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd.20119—
+3K233266Mediblu Ecg SystemMediblu Medical, LLC20240—
+3K180432AI-ECG PlatformShenzhen Carewell Electronics., Ltd.20180—
+3K171942ElectrocardiographEdan Instruments, Inc.20183—
+3K170995ElectrocardiographEdan Instruments, Inc.20173—
+3K131900Contec ElectrocardiographContec Medical System Co., Ltd.20141—
+3K132758Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20141—
+3K131262Digital ElectrocardiographsSonoscape Company Limited20130—
+3K123816Digital ElectrocardiographsShenzhen Biocare Electronics Co., Ltd.20134—
+4K212278ElectrocardiographEdan Instruments, Inc.20222—
+4K220362LE-12CHCaf Medical Solutions, Inc.20220—
+4K210140electrocardiograph: SE-1202Edan Instruments, Inc.20211—
+4K171360CONTEC™ ElectrocardiographContec Medical Systems Co.,Ltd20180—
+4K133985Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20151—
+5K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.20260—
+5K222902Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc.20231—
+5K152384Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20150—
+6K232210X-trodes System MX-Trodes20240—