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

    TT1 GENERAL PURPOSE COIL

    K Number: K083434 · Decision Dec 23, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    478
    Applicant Total
    2
    Review Days
    33

    Basic Information

    Device Name
    TT1 GENERAL PURPOSE COIL
    K Number
    K083434
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    TURSIOP TECHNOLOGIES LLC
    Date Received
    November 20, 2008
    Decision Date
    December 23, 2008
    Product Code
    MOS
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    MOS Coil, Magnetic Resonance, Specialty

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