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

    NONINVASIVE BLOOD PRESSURE MEASURE SYS

    K Number: K841103 · Decision Oct 26, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    9
    Review Days
    226

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    Basic Information

    Device Name
    NONINVASIVE BLOOD PRESSURE MEASURE SYS
    K Number
    K841103
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Panasonic Co. Div. Matsu Elec. Corp. America
    Date Received
    March 14, 1984
    Decision Date
    October 26, 1984
    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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    Other Clearances by Panasonic Co. Div. Matsu Elec. Corp. America

    K Number Device Name
    K860634 PANASONIC BLOOD PRESSURE METER, ZH-852AP, ZH-858PP
    K832076 ELECTRONIC BLOOD PRESS. METER EN-212
    K833510 PANASONIC WH-50 HEARING AID
    K832075 ELECTRONIC BLOOD PRESS. METER-ZH-820P
    K831151 PANASONIC MODEL EW-213
    K831150 PANASONIC MODEL HV-5
    K823285 MODEL WHO1 HEARING AID
    K821972 HEARING AID VARIOUS MODELS