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

    TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES

    K Number: K111131 · Decision Jun 17, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    42
    Applicant Total
    5
    Review Days
    57

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    Basic Information

    Device Name
    TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
    K Number
    K111131
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.1385
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carefusion 209, Inc.
    Date Received
    April 21, 2011
    Decision Date
    June 17, 2011
    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 Carefusion 209, Inc.

    K Number Device Name
    K120979 CAREFUSION NICOLET EDX
    K112052 CAREFUSION NICOLET EDX
    K112034 TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
    K103140 NICOLET WIRELESS EEG