BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    NEONATE ARRAY COILS

    K Number: K091047 · Decision Aug 18, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    2
    Review Days
    492

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    Basic Information

    Device Name
    NEONATE ARRAY COILS
    K Number
    K091047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lmt Medical Systems GmbH
    Date Received
    April 13, 2009
    Decision Date
    August 18, 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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    Other Clearances by Lmt Medical Systems GmbH

    K Number Device Name
    K171515 NHAC 16