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

    PROTECTRODE SYSTEM

    K Number: K926094 · Decision Dec 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    52
    Applicant Total
    6
    Review Days
    1099

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    Basic Information

    Device Name
    PROTECTRODE SYSTEM
    K Number
    K926094
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1350
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Electrode Store, Inc.
    Date Received
    December 2, 1992
    Decision Date
    December 6, 1995
    Product Code
    GXZ
    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
    GXZ Electrode, Needle

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    Other Clearances by The Electrode Store, Inc.

    K Number Device Name
    K083758 SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS
    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
    K932691 PROTECTRODE SYSTEMS CONCENTRIC