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

    NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES

    K Number: K973529 · Decision Nov 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    42
    Applicant Total
    7
    Review Days
    63

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    Basic Information

    Device Name
    NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES
    K Number
    K973529
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1385
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medicotest A/S
    Date Received
    September 18, 1997
    Decision Date
    November 20, 1997
    Product Code
    IKT
    Advisory Committee
    Physical Medicine
    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
    IKT Electrode, Needle, Diagnostic Electromyograph

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    Other Clearances by Medicotest A/S

    K Number Device Name
    K020382 BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA
    K020907 NEUROLINE, SUBDERMAL NEEDLE ELECTRODES
    K002079 MULTI-FUNCTION DEFIBRILLATION ELECTRODE
    K001869 DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE
    K983689 BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES
    K965194 MEDICOM, TENS ELECTRODES