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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    MSTAR MPD4500

    K Number: K073457 · Decision Feb 1, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    1
    Review Days
    53

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    Basic Information

    Device Name
    MSTAR MPD4500
    K Number
    K073457
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Xinaomdt Technology Co., Ltd.
    Date Received
    December 10, 2007
    Decision Date
    February 1, 2008
    Product Code
    LNH
    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
    LNH System, Nuclear Magnetic Resonance Imaging

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