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

    BRAIN COIL, MODEL 9800GE-64

    K Number: K003097 · Decision Dec 28, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    9
    Review Days
    86

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    Basic Information

    Device Name
    BRAIN COIL, MODEL 9800GE-64
    K Number
    K003097
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Midwest Rf, LLC
    Date Received
    October 3, 2000
    Decision Date
    December 28, 2000
    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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