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

    SUNSPOTS PRE-GELLED SURFACE ELECTRODES

    K Number: K062198 · Decision Dec 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    15
    Review Days
    140

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    Basic Information

    Device Name
    SUNSPOTS PRE-GELLED SURFACE ELECTRODES
    K Number
    K062198
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Axon Systems, Inc.
    Date Received
    August 1, 2006
    Decision Date
    December 19, 2006
    Product Code
    GXY
    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
    GXY Electrode, Cutaneous

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    Other Clearances by Axon Systems, Inc.

    K Number Device Name
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    K061113 ORTHOMON
    K050798 ECLIPSE NEUROLOGICAL WORKSTATION
    K050194 AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES
    K032741 EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION
    K022785 EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION
    K010697 UNIQUE AMBULATORY EEG
    K002316 PHOENIX DIGITAL EEG
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