BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230

    K Number: K091546 · Decision Jun 24, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    10
    Review Days
    28

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    Basic Information

    Device Name
    NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230
    K Number
    K091546
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Noras Mri Products GmbH
    Date Received
    May 27, 2009
    Decision Date
    June 24, 2009
    Product Code
    MOS
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    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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