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

    OXYGENATOR, BUBBLE TYPE

    K Number: K780078 · Decision Sep 14, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    249
    Applicant Total
    55
    Review Days
    240

    Basic Information

    Device Name
    OXYGENATOR, BUBBLE TYPE
    K Number
    K780078
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    BENTLEY LABORATORIES, INC.
    Date Received
    January 17, 1978
    Decision Date
    September 14, 1978
    Product Code
    DTZ
    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
    DTZ Oxygenator, Cardiopulmonary Bypass

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    Other Clearances by BENTLEY LABORATORIES, INC.

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    K894826 UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF
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    K874618 BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER
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