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510(k) Data Aggregation

    K Number
    K201332
    Device Name
    Meditech ABPM-06 (BP6)
    Manufacturer
    Meditech Ltd.
    Date Cleared
    2021-02-10

    (267 days)

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

    Meditech Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Meditech ABPM-06 (BP6) Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications for ambulatory blood pressure monitoring.
    Device Description
    Ambulatory Blood Pressure Monitor
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