BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SHARP DIGITAL BP MONITOR MB-371H

    K Number: K850830 · Decision Jun 13, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    10
    Review Days
    127

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    Basic Information

    Device Name
    SHARP DIGITAL BP MONITOR MB-371H
    K Number
    K850830
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Sharp Electronics Corp.
    Date Received
    February 6, 1985
    Decision Date
    June 13, 1985
    Product Code
    DXN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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