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

    MINI-DOPPLER ES-100

    K Number: K840542 · Decision Jul 16, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    71
    Applicant Total
    1
    Review Days
    159

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    Basic Information

    Device Name
    MINI-DOPPLER ES-100
    K Number
    K840542
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2880
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Hayashi Denki Co., Ltd.
    Date Received
    February 8, 1984
    Decision Date
    July 16, 1984
    Product Code
    JOP
    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
    JOP Transducer, Ultrasonic

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