510(k) Report

Devices descending from K961301

112 later devices reach E-Scope Electronic Stethoscope Model 718-7120 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103499A ScopeActive Signal Technologies, Inc.20110—
+1K060194March Healthcare Health Monitoring KitMarch Healthcare Corporation20065—
+1K030316Audicor Cor Sensor (and Accessory Adaptor)Inovise Medical, Inc.20032—
+1K991367Meditron Stethoscope SystemMeditron AS199951—
+1K990809Cadiscope Electronic StethoscopeCaditec AG199966—
+2K100531Viscope, Model 100P,100SHd Medical Services (India) Pvt.Ltd20100—
+2K091732Vrlxp, Model XPDeep Breeze, Ltd.20100—
+2K090493SignalZargis Medical Corp.20091—
+2K090801Electronic House CallExpress MD Solutions, LLC20093—
+2K082528Snor-Scope Plus or Snor-Scope + Electronic Stethoscope SystemNoble Anesthesia-Air, Inc.20090—
+2K080602Audicor Sensor, Models: 2.0, 3.0Inovise Medical, Inc.20081—
+2K072026RNK Electronic StethoscopeRnk Products, Inc.200729—
+2K061495VR Lung ElectrosonographDeep Breeze, Ltd.20072—
+2K062338TelevisitPHD Medical20060—
+2K050097Techno-Scope Visual StethoscopeTechtrade, LLC20050—
+2K051126Cardioscope Sonoplus 3000Pulsonic Ag, Medical Technology20050—
+2K031446Jabes Electronic StethoscopeGs Technology Co., Ltd.20033—
+2K013434VP-2000/1000Colin Corp.200246—
+2K013725Meditron II Thesterthoscope SystemMeditron AS200216—
+3K222153Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)Microlife Intellectual Property GmbH20230—
+3K132405Ppa/BT-RB StethoscopeRnk Products, Inc.20130—
+3K112521Fukuda Denshi Vasera Model VS-1500Fukuda Denshi USA, Inc.20110—
+3K112845Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20113—
+3K102063Health-E-Connect SystemAlr Technologies20111—
+3K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+3K103516Audicor Sensor-Adapter Model Audicor Sensor-Adapter 4.0Inovise Medical, Inc.20110—
+3K102893PCP/PC StethoscopeRnk Products, Inc.201126—
+3K093895Ally Platform SystemContinuity Health Solutions20100—
+3K093205PadcheckPadtest, LLC20100—
+3K082357Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office…Microlife Intellectual Property GmbH200827—
+3K073582Vriicu SystemDeep Breeze, Ltd.20081—
+3K080670Modification to Sphygmocor Cardiovascular Management SystemAtcor Medical20088—
+3K062364I-Scope 200Dongjin Medical Co., Ltd.20060—
+3K062481Sereno Electronic StethoscopePishon High Tech Co., Ltd.20061—
+3K050233Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model Hem-9000AIOmron Healthcare, Inc.20056—
+4K171937Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20181—
+4K163664Health-e-Connect System with IDAAlr Technologies20170—
+4K160401Tyto StethoscopeTyto Care, Ltd.201621—
+4K151869Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH, Switzerland201515—
+4K132560PCP-Usb StethoscopeRnk Products, Inc.20133—
+4K131287CardiosleeveRijuven Corp20131—
+4K122129Sphygmocor XcelAtcor Medical20126—
+4K121617SensicardiacDiacoustic Medical (Pty)201210—
+4K110645Bio Z Cardio Profile Hemodynamic MonitorSonosite,Inc.20110—
+4K101512Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watchbp Office Target…Microlife Intellectual Property GmbH20100—
+4K101275Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Watch BP Office Afib…Microlife Intellectual Property GmbH20106—
+4K081654HEM-9000AIOmron Healthcare, Inc.20080—
+4K072593A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd.20074—
+5K253306BioTracker 2.0Biotracker, LLC20260—
+5K221742Conneqt PulseAtcor Medical20230—
+5K202483MyHomeDocMyhomedoc, Ltd.20211—
+5K201299HD StethHd Medical, Inc.20200—
+5K190927Oscillometric Blood Pressure MonitorRudolf Riester GmbH20190—
+5K181612Tyto Stethoscope (OTC)Tyto Care, Ltd.201819—
+5K180155Arm Type Blood Pressure MonitorAvita Corporation20180—
+5K172431Cardiovascular AnalzyerPhysiowave, Inc.20180—
+5K170467Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20170—
+5K151520Oscar 2Suntech Medical, Inc.201632
+5K153077Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH201612—
+5K150782AbStats GatewayGi Logic, Inc.20152—
+5K143341Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20154—
+5K131916Bprosoft Casp PC SoftwareHealthstats International Pte., Ltd.20140—
+5K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+5K101002A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200Healthstats International Pte., Ltd.20102—
+6K252089Tyto Stethoscope (G3)Tyto Care, Ltd.20260—
+6K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd.20260—
+6K252474Withings BeamO (SCT02)Withings20250—
+6K222979Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5WMicrolife Intellectual Property GmbH20235—
+6K223785N9+Nonagon, Ltd.20230—
+6K212906HeartBuds Electronic StethoscopeHeartbuds, LLC20230—
+6K223166Medaica M1 Telehealth StethoscopeMedaica, Inc.20230—
+6K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc.20211—
+6K211068PrevisEA DeviceEntac Medical, Inc.20211—
+6K200521Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.20200—
+6K200776Eko COREEko Devices, Inc.202013—
+6K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+6K190818Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20190—
+6K181988eMurmur IDCsd Labs GmbH20197—
+6K172498Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4YMicrolife Intellectual Property GmbH20173—
+6K152770ProBP 2400 Digital Blood Pressure DeviceMicrolife Intellectual Property GmbH201531
+6K131788Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application…Healthstats International Pte., Ltd.20140—
+6K121266CardioscopePulsecor Limited20120—
+7K261694CORE 300 Digital StethoscopeEko Health, Inc.20260—
+7K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+7K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+7K233313Keikku Electronic stethoscopeLapsi Health Holding B.V.20240—
+7K232621Blood pressure monitorGuangdong Transtek Medical Electronics Co., Ltd.20233—
+7K231551StethophoneSparrow Acoustics, Inc.20232—
+7K230613SkeeperSmartsound Corporation20230—
+7K230823AusculThing ACCAusculthing OY20230—
+7K230075Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5KMicrolife Intellectual Property GmbH20232—
+7K230769PrevisEA DeviceEntac Medical, Inc.20230—
+7K220099eClinic StethopodHomediagnostic, LLC20220—
+7K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+7K220766eMurmur Heart AICsd Labs GmbH20221—
+7K220470Smart Wireless StethoscopeShanghai Hulu Devices Co., Ltd.20221—
+7K220196Steth IO SpotStratoscientific20220—
+7K210736doctorgram Stethoscope DES-IGv Concepts20212—
+7K200297Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20202—
+8K253425Arm-type Fully Automatic Digital Blood Pressure Monitor…Joytech Healthcare Co., Ltd.20260—