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

    IRRIGATION/ASPIRATION TUBING SET

    K Number: K911324 · Decision Jun 24, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    22
    Applicant Total
    10
    Review Days
    90

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    Basic Information

    Device Name
    IRRIGATION/ASPIRATION TUBING SET
    K Number
    K911324
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Biomedical Dynamics, Inc.
    Date Received
    March 26, 1991
    Decision Date
    June 24, 1991
    Product Code
    KDH
    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
    KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

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    Other Clearances by Biomedical Dynamics, Inc.

    K Number Device Name
    K915074 IRRIGATOR/ASPIRATOR PROBE
    K913751 PRESSURE INFUSER
    K911213 CUFFABLE
    K911216 INFUSABLE
    K904376 ANEROID BLOOD PRESSURE GAUGE
    K890268 PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION
    K881799 BLOOD PRESSURE CUFF
    K861977 BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR
    K850506 CORRECT FLO INTRAVASCULAR ADMINISTRATION SET