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

    UNIQUE AMBULATORY EEG

    K Number: K010697 · Decision Jun 6, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    188
    Applicant Total
    15
    Review Days
    90

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    Basic Information

    Device Name
    UNIQUE AMBULATORY EEG
    K Number
    K010697
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Axon Systems, Inc.
    Date Received
    March 8, 2001
    Decision Date
    June 6, 2001
    Product Code
    GWQ
    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
    GWQ Full-Montage Standard Electroencephalograph

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    Other Clearances by Axon Systems, Inc.

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    K061113 ORTHOMON
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