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

    INFANT ARRAY

    K Number: K113365 · Decision Mar 29, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    2
    Review Days
    135

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    Basic Information

    Device Name
    INFANT ARRAY
    K Number
    K113365
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Imaging Research Dba Sree Medical Systems
    Date Received
    November 15, 2011
    Decision Date
    March 29, 2012
    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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