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

    ELS AUTOMATIC TUBING CLAMP SYSTEM

    K Number: K921993 · Decision Jan 5, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    5
    Review Days
    617

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    Basic Information

    Device Name
    ELS AUTOMATIC TUBING CLAMP SYSTEM
    K Number
    K921993
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rocky Mountain Research, Inc.
    Date Received
    April 28, 1992
    Decision Date
    January 5, 1994
    Product Code
    FIG
    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
    FIG Clamp, Tubing, Blood, Automatic

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