BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    MERIDIAN-PORTABLE

    K Number: K010897 · Decision Jun 19, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    25
    Applicant Total
    7
    Review Days
    85

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    Basic Information

    Device Name
    MERIDIAN-PORTABLE
    K Number
    K010897
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1540
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meridian Co., Ltd.
    Date Received
    March 26, 2001
    Decision Date
    June 19, 2001
    Product Code
    GZO
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GZO Device, Galvanic Skin Response Measurement

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    K001347 MERIDIAN-II AND MERDIAN-PLUS