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

    ELS AUTOMATIC TUBING CLAMP SYSTEM

    K Number: K961598 · Decision Oct 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    13
    Applicant Total
    5
    Review Days
    203

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    Basic Information

    Device Name
    ELS AUTOMATIC TUBING CLAMP SYSTEM
    K Number
    K961598
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4205
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rocky Mountain Research, Inc.
    Date Received
    April 9, 1996
    Decision Date
    October 29, 1996
    Product Code
    KRL
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KRL Detector, Bubble, Cardiopulmonary Bypass

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