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

    ELLIPSE 4

    K Number: K964522 · Decision Mar 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    129

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    Basic Information

    Device Name
    ELLIPSE 4
    K Number
    K964522
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Andromeda Medizinische Systeme GmbH
    Date Received
    November 12, 1996
    Decision Date
    March 21, 1997
    Product Code
    FEN
    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
    FEN Device, Cystometric, Hydraulic

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