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510(k) Data Aggregation

    K Number
    K955887
    Device Name
    NEWMED ABP-LITE
    Manufacturer
    NEWMED CORP.
    Date Cleared
    1996-09-05

    (252 days)

    Product Code
    DXW
    Regulation Number
    870.1270
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEWMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the ABP-lite is to detect, diagnose, and monitor hypertension.
    Device Description
    The ABP-lite is a 24-hour Ambulatory Blood Pressure Monitoring System (ABPMS) which obtains and stores the results of repeated determinations of blood pressure and heart rate during the activities of ordinary daily living. The ABP-lite system also manages a patient data base. The ABP-lite ABPMS includes a pneumatic cuff (worn by the patient), Data Recorder Unit (worn by the patient -- collects blood pressure ("BP") and heart rate ("HR") data), Remote Control Unit (LCD display of BP and HR data as well as error codes, patient control functions of event button and stop ongoing test). Interface Unit (interface between Remote Control Unit and PC), and ABPM-Soft Analyzer (proprietary custom software used for initial setup of Data Recorder, plus download, processing and printing of collected data). The ABP-lite system weighs 13 ounces and is 21 cubic inches in size. The ABP-lite system uses the Korotkoff and oscillometric methods of blood pressure measurement with blood pressure cuff and microphone technology. Safety systems include an emergency pressure release system and watchdog timer.
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