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510(k) Data Aggregation

    K Number
    K983616
    Device Name
    DAIWA MODEL 180
    Date Cleared
    1999-10-15

    (366 days)

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

    DAIWA PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Daiwa Model 180 Automatic Inflation Wrist Digital Blood Pressure Monitor is designed to provide signals from which systolic and diastolic pressures can be derived through the use of the oscillometric method. The device also measures the heart rate. The device is for adult use only and measures wrist circumferences from 5 1/4" to 7 3/4". The end user should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation
    Device Description
    Automatic Inflation Wrist Digital Blood Pressure Monitors
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