510(k) Report

Devices descending from K031422

27 later devices reach Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072449CP100 & 200 12-Lead Resting ElectrocardiographsWelch Allyn, Inc.20077—
+1K060167Atria 3100, Atria 6100Cardiac Science Corporation200611—
+1K051228Biozdx Hemodynamic Monitor and 12-Lead EcgCardiodynamics International Corp.20055—
+1K05007412-Lead Resting Electrocardiograph, Models CP100 & CP200Welch Allyn, Inc.200512—
+2K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170—
+2K160876PC ECGEdan Instruments, Inc.20178—
+2K142352CardiacLinxRoss Medical Technology, Inc.20150—
+2K131573CP150 ElectrocardiographWelch Allyn, Inc.20131—
+2K102767Cardio XPBionet Co., Ltd.20114—
+2K090602Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp.20091—
+2K070156Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp.20074—
+3K171942ElectrocardiographEdan Instruments, Inc.20183—
+3K160899CoVa Monitoring System 2Tosense, Inc.20170—
+3K170995ElectrocardiographEdan Instruments, Inc.20173—
+3K141582CP150 Electrocardiograph with Spirometry OptionWelch Allyn201402
+3K113306Cardio 7Bionet Co., Ltd.20123—
+3K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+3K080941Bioimpedance Cardiac Analyzing Measuring SystemN.I. Medical, Ltd.20090—
+4K220535Cardio10Bionet Co., Ltd.20222—
+4K212278ElectrocardiographEdan Instruments, Inc.20222—
+4K220362LE-12CHCaf Medical Solutions, Inc.20220—
+4K210140electrocardiograph: SE-1202Edan Instruments, Inc.20211—
+5K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.20260—
+5K231160Cardio Q50, Cardio Q70Bionet Co., Ltd.20230—
+5K231150Cardio P1Bionet Co., Ltd.20230—
+5K222902Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc.20231—
+6K232210X-trodes System MX-Trodes20240—