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

    THE ADDITION

    K Number: K102683 · Decision Jan 6, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    33
    Applicant Total
    1
    Review Days
    111

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    Basic Information

    Device Name
    THE ADDITION
    K Number
    K102683
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ob The-Addition, LLC
    Date Received
    September 17, 2010
    Decision Date
    January 6, 2011
    Product Code
    MUI
    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
    MUI Media, Coupling, Ultrasound

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