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

    SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS

    K Number: K083758 · Decision Aug 14, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    6
    Review Days
    240

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    Basic Information

    Device Name
    SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS
    K Number
    K083758
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Electrode Store, Inc.
    Date Received
    December 17, 2008
    Decision Date
    August 14, 2009
    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 The Electrode Store, Inc.

    K Number Device Name
    K022197 SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY
    K020910 SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF
    K020445 THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG
    K926094 PROTECTRODE SYSTEM
    K932691 PROTECTRODE SYSTEMS CONCENTRIC