510(k) Report

Devices descending from K092010

18 later devices reach PC Ecg, Model SE-1010 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152384Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20150—
+1K133985Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20151—
+1K131503SE-601 Series ElectrocardiographEdan Instruments, Inc.20149—
+1K102854PC ECGEdan Instruments, Inc.201013—
+1K093869SE-601 Series ElectrocardiographEdan Instruments, Inc.201010—
+2K160876PC ECGEdan Instruments, Inc.20178—
+2K131819PC ECGEdan Instruments, Inc.201312—
+3K171942ElectrocardiographEdan Instruments, Inc.20183—
+3K170995ElectrocardiographEdan Instruments, Inc.20173—
+3K152427PC ECGEdan Instruments, Inc.201611—
+4K212278ElectrocardiographEdan Instruments, Inc.20222—
+4K220362LE-12CHCaf Medical Solutions, Inc.20220—
+4K210140electrocardiograph: SE-1202Edan Instruments, Inc.20211—
+4K161302PC ECGEdan Instruments, Inc.20161—
+5K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.20260—
+5K222902Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc.20231—
+5K191692KardioScreenImedrix Inc. (Formerly Piitech Inc.)20200—
+6K232210X-trodes System MX-Trodes20240—