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

    POLYPLEX STIMULATING CATHETER SYSTEM

    K Number: K060186 · Decision Jul 18, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    154
    Applicant Total
    2
    Review Days
    175

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    Basic Information

    Device Name
    POLYPLEX STIMULATING CATHETER SYSTEM
    K Number
    K060186
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5140
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Te ME NA Sas
    Date Received
    January 24, 2006
    Decision Date
    July 18, 2006
    Product Code
    CAZ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CAZ Anesthesia Conduction Kit

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