510(k) Report

Devices descending from K964750

115 later devices reach Eagle 4000 Patient Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+8K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.20182—
+8K170155EK12 AlgorithmGe Medical Systems Information Technologies, Inc.20171—
+8K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien201601
+8K152993MUSE Cardiology Information SystemGe Medical Systems Information Technologies, Inc.201611
+8K152384Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20150—
+8K133703Physioglove ET SystemCommwell R&D, Ltd.20140—
+9K252589Corvair MonzaAliveCor, Inc.20260—
+9K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+9K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+9K221904EK12 V2 AlgorithmGe Medical Systems Information Technologies, Inc.20220—
+9K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+9K201060Cordiana Dx16Cordiana Medical Informatics AG20200—
+10K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+10K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401