510(k) Report

Devices descending from K895520

58 later devices reach Pagewriter Xli M1700A & Pagewriter XL M1701A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170—
+1K020708Philips Pagewriter Touch Cardiograph, Model M5000A SeriesPhilips Medical Systems, Inc.2002472
+1K961272Nihon Kohden Ecg-9320A Cardiofax and AccessoriesNihon Kohden America, Inc.19960—
+1K954980Pagewriter 200, 200I Cardiograph & Interpretive CardioHewlett-Packard Co.19968—
+2K132068Philips DXL 12/16-Lead Ecg AlgorithmPhilips Medical Systems20130—
+2K123130Answatch Wrist Monitor Model TS-0411Taiwan Scientific Corporation20132—
+2K080999Pagewriter CardiographPhilips Medical Systems20087—
+2K073376Philips Ecg AlgorithmPhilips Medical Systems20085—
+2K080036Portable Ecscope 12IDyansys, Inc.20082—
+2K072353Portable EcscopeDyansys Corp20075—
+2K052049Philips 12-Lead AlgorithmPhilips Medical Systems20057—
+2K032200Elan Digital 12 Channel ElectrocardiographRemco Italia S.P.A.20036—
+2K031422Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models 860286, 860287…Philips Medical Systems200327—
+2K982025Hewlett-Packard M2475B with 12-Lead Option (#C90) Codemaster 100 Conitor/DefibrillatorHewlett-Packard Co.19980—
+3K213699CareTaker Monitor AppCaretaker Medical, LLC20220—
+3K201914HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation20210—
+3K191738PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph…Philips Medical Systems20203—
+3K113144Pagewriter TC 20, 30, 50, 70Philips Medical Systems201259
+3K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems20104—
+3K093172Quantitative Electrocardiographic Detector (Qed 1000)Dynacardia, Inc.20100—
+3K091397Ecscope 200Dyansys, Inc.20090—
+3K091358Ecscope 100Dyansys, Inc.20090—
+3K082013Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin20081—
+3K072449CP100 & 200 12-Lead Resting ElectrocardiographsWelch Allyn, Inc.20077—
+3K060167Atria 3100, Atria 6100Cardiac Science Corporation200611—
+3K051228Biozdx Hemodynamic Monitor and 12-Lead EcgCardiodynamics International Corp.20055—
+3K05007412-Lead Resting Electrocardiograph, Models CP100 & CP200Welch Allyn, Inc.200512—
+4K210560Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50…Philips Medical Systems20212—
+4K160876PC ECGEdan Instruments, Inc.20178—
+4K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc.20160—
+4K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+4K151812Patient Monitors Various ModelsPhilips Medical Systems20160—
+4K150082Panorama Patient Monitoring NetworkShenzhen Mindray Bio-Medical Electronics Co., Ltd.201501
+4K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+4K142352CardiacLinxRoss Medical Technology, Inc.20150—
+4K131573CP150 ElectrocardiographWelch Allyn, Inc.20131—
+4K102767Cardio XPBionet Co., Ltd.20114—
+4K090602Cardiodynamics Bioz RX, Model 7101-SysCardiodynamics International Corp.20091—
+4K083630Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin20090—
+4K070156Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100Cardiodynamics International Corp.20074—
+5K241556Cardiac Workstation (5000); Cardiac Workstation (7000)Philips Medizin Systeme Böblingen GmbH202404
+5K221141PageWriter TC35 CardiographMedizin Systeme Boblingen GmbH20220—
+5K171942ElectrocardiographEdan Instruments, Inc.20183—
+5K160899CoVa Monitoring System 2Tosense, Inc.20170—
+5K170995ElectrocardiographEdan Instruments, Inc.20173—
+5K141582CP150 Electrocardiograph with Spirometry OptionWelch Allyn201402
+5K113306Cardio 7Bionet Co., Ltd.20123—
+5K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+5K080941Bioimpedance Cardiac Analyzing Measuring SystemN.I. Medical, Ltd.20090—
+6K220535Cardio10Bionet Co., Ltd.20222—
+6K212278ElectrocardiographEdan Instruments, Inc.20222—
+6K220362LE-12CHCaf Medical Solutions, Inc.20220—
+6K210140electrocardiograph: SE-1202Edan Instruments, Inc.20211—
+7K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.20260—
+7K231160Cardio Q50, Cardio Q70Bionet Co., Ltd.20230—
+7K231150Cardio P1Bionet Co., Ltd.20230—
+7K222902Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc.20231—
+8K232210X-trodes System MX-Trodes20240—