510(k) Report

Devices descending from K060833

21 later devices reach 12SL Ecg Analysis Program through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142288MAC 800 Resting ECG Analysis SystemGe Medical Systems China Co., Ltd.20140—
+1K09236912SL Ecg Analysis ProgramGe Medical Systems Information Technologies201019—
+2K162012CARESCAPE Central Station V2GE Healthcare201676
+2K14196312SL Ecg Analysis ProgramGe Medical Systems Information Technologies, Inc.20156—
+2K133882Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc.201491
+2K103791Physioglove ES with Ecg AnalysisCommwell, Ltd.20111—
+3K231010CorvairAliveCor, Inc.20241—
+3K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+3K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.20182—
+3K170155EK12 AlgorithmGe Medical Systems Information Technologies, Inc.20171—
+3K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien201601
+3K152993MUSE Cardiology Information SystemGe Medical Systems Information Technologies, Inc.201611
+3K133703Physioglove ET SystemCommwell R&D, Ltd.20140—
+4K252589Corvair MonzaAliveCor, Inc.20260—
+4K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+4K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+4K221904EK12 V2 AlgorithmGe Medical Systems Information Technologies, Inc.20220—
+4K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+4K201060Cordiana Dx16Cordiana Medical Informatics AG20200—
+5K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+5K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401