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

    16 CH MULTIPURPOSE COIL VARIETY

    K Number: K140252 · Decision May 8, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    2
    Review Days
    97

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    Basic Information

    Device Name
    16 CH MULTIPURPOSE COIL VARIETY
    K Number
    K140252
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Noras Rontgen-Und Medizintechnik GmbH
    Date Received
    January 31, 2014
    Decision Date
    May 8, 2014
    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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    Other Clearances by Noras Rontgen-Und Medizintechnik GmbH

    K Number Device Name
    K052987 BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC