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

    SARNS INFANT ARTERIAL BUBBLE SENSOR

    K Number: K803105 · Decision Dec 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    39
    Applicant Total
    76
    Review Days
    22

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    Basic Information

    Device Name
    SARNS INFANT ARTERIAL BUBBLE SENSOR
    K Number
    K803105
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5220
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    3M Health Care, Sarns
    Date Received
    December 9, 1980
    Decision Date
    December 31, 1980
    Product Code
    KPL
    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
    KPL Colonic Irrigation System

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