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

    DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE

    K Number: K912283 · Decision Mar 16, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    42
    Applicant Total
    21
    Review Days
    298

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    Basic Information

    Device Name
    DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
    K Number
    K912283
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1385
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Chalgren Enterprises, Inc.
    Date Received
    May 23, 1991
    Decision Date
    March 16, 1992
    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 Chalgren Enterprises, Inc.

    K Number Device Name
    K982950 FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550
    K960591 RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP
    K955335 DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE
    K953356 EMG RECORDING RING ELECTRODE
    K953354 EMG DISC RECORDING ELECTRODE
    K953361 EMG DISC RECORDING ELECTRODE
    K952690 EMG DISC RECORDING ELECTRODE WITH PIN
    K952908 EMG DISC RECORDING ELECTRODE WITH PIN
    K953886 RE-USABLE MONOPOLAR NEEDLE
    K953887 RE-USABLE CONCENTRIC NEEDLE
    Search all 21 clearances from Chalgren Enterprises, Inc. →