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

    VENOUS RESERVOIR-BMR-1500-HARD SHELL

    K Number: K842373 · Decision Dec 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    33
    Applicant Total
    59
    Review Days
    195

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    Basic Information

    Device Name
    VENOUS RESERVOIR-BMR-1500-HARD SHELL
    K Number
    K842373
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4230
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    American Bentley
    Date Received
    June 15, 1984
    Decision Date
    December 27, 1984
    Product Code
    DTP
    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
    DTP Defoamer, Cardiopulmonary Bypass

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