BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    OHMEGA

    K Number: K060166 · Decision Apr 21, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    67
    Applicant Total
    7
    Review Days
    88

    Basic Information

    Device Name
    OHMEGA
    K Number
    K060166
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1725
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    MEDICAL MEASUREMENT SYSTEMS,B.V.
    Date Received
    January 23, 2006
    Decision Date
    April 21, 2006
    Product Code
    FFX
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FFX System, Gastrointestinal Motility (Electrical)

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