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

    CUTANEOUS ELECTRODES

    K Number: K142099 · Decision Nov 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    17
    Review Days
    108

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    Basic Information

    Device Name
    CUTANEOUS ELECTRODES
    K Number
    K142099
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bio Protech, Inc.
    Date Received
    August 1, 2014
    Decision Date
    November 17, 2014
    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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    K111270 REUSABLE STIMULATING ELECTRODES
    K100246 MAX-IF1000
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