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

    EPOCH 2000 NEUROLOGICAL WORKSTATION

    K Number: K971819 · Decision Nov 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    15
    Review Days
    188

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    Basic Information

    Device Name
    EPOCH 2000 NEUROLOGICAL WORKSTATION
    K Number
    K971819
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Axon Systems, Inc.
    Date Received
    May 16, 1997
    Decision Date
    November 20, 1997
    Product Code
    GWF
    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
    GWF Stimulator, Electrical, Evoked Response

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    Other Clearances by Axon Systems, Inc.

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    K050194 AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES
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