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

    14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA

    K Number: K100141 · Decision Aug 27, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    478
    Applicant Total
    519
    Review Days
    220

    Basic Information

    Device Name
    14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA
    K Number
    K100141
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Date Received
    January 19, 2010
    Decision Date
    August 27, 2010
    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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