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

    SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64

    K Number: K051618 · Decision Aug 2, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    9
    Review Days
    46

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    Basic Information

    Device Name
    SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64
    K Number
    K051618
    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
    June 17, 2005
    Decision Date
    August 2, 2005
    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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