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

    OPTAX SYSTEM

    K Number: K020800 · Decision Jun 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    OPTAX SYSTEM
    K Number
    K020800
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Optax Systems, Inc.
    Date Received
    March 12, 2002
    Decision Date
    June 10, 2002
    Product Code
    LQD
    Advisory Committee
    Unknown
    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
    LQD Recorder, Attention Task Performance

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