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510(k) Data Aggregation

    K Number
    K991545
    Device Name
    WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK
    Manufacturer
    INDUSTRIELLE ENTWICKLUNG MEDIZINTECHNIK UND VERTRI
    Date Cleared
    2000-01-19

    (261 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    INDUSTRIELLE ENTWICKLUNG MEDIZINTECHNIK UND VERTRI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KLOCK Blood Pressure Monitor is to be used by adults as a Home Health Care device to monitor Blood Pressure (systolic and diastolic) and the Pulse rate at home. The Blood Pressure Measurement is obtained by the use of the oscillometric method, meaning that the monitor detects the blood's movement through the artery in the wrist and converts the movements into digital readings. The KLOCK is not intended to be used by people who have circulatory problems, such as arrhythmia, or if pregnant.
    Device Description
    Watch Style Wrist Digital Blood Pressure Monitor
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    K Number
    K964235
    Device Name
    ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL
    Manufacturer
    INDUSTRIELLE ENTWICKLUNG MEDIZINTECHNIK UND VERTRI
    Date Cleared
    1999-03-02

    (860 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    INDUSTRIELLE ENTWICKLUNG MEDIZINTECHNIK UND VERTRI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This portable device, the ABPM Mobil-o- Graph "" Blood Pressure Monitor manufactured by I.E.M. GmbII is an automated, microprocessor controlled blood pressure monitor which monitors, accumulates and stores: heart beat (rate) systolic und diastolic data of a individual adult-patient (in the patient's environment) for a session which may last 24 to 48 hours.
    Device Description
    ABPM Nobil-o- Graph™ Blood Pressure Monitor, Model ABP Control is a computerized blood pressure system designed for clinical applications to allow physicians or other health care providers to record, store, and playback patient data.
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