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

    MEDACORD PVL, PERSONAL VASCULAR LABORATORY

    K Number: K882018 · Decision Sep 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    19
    Review Days
    131

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    Basic Information

    Device Name
    MEDACORD PVL, PERSONAL VASCULAR LABORATORY
    K Number
    K882018
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1540
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Medasonics, Inc.
    Date Received
    May 13, 1988
    Decision Date
    September 21, 1988
    Product Code
    JAF
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JAF Monitor, Ultrasonic, Nonfetal

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