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

    EP-100 (SERIES)

    K Number: K884415 · Decision Feb 28, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    47
    Same Product Code
    58
    Applicant Total
    5
    Review Days
    131

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    Basic Information

    Device Name
    EP-100 (SERIES)
    K Number
    K884415
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Stereotactic Medical Systems, Inc.
    Date Received
    October 20, 1988
    Decision Date
    February 28, 1989
    Product Code
    FPD
    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
    FPD Tube, Feeding

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    Other Clearances by Stereotactic Medical Systems, Inc.

    K Number Device Name
    K896156 COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM
    K883653 EP-100 INFUSION PUMP
    K871046 COMPASS STEREOTACTIC POSITIONING SYSTEM
    K862220 COMPASS CT STEREOTACTIC ADAPTATION SYSTEM