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

    MRI EQUIPMENT COVER

    K Number: K993682 · Decision Jan 20, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    22
    Review Days
    80

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    Basic Information

    Device Name
    MRI EQUIPMENT COVER
    K Number
    K993682
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Image-Guided Neurologics, Inc.
    Date Received
    November 1, 1999
    Decision Date
    January 20, 2000
    Product Code
    LNH
    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
    LNH System, Nuclear Magnetic Resonance Imaging

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