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

    SORIN MONOLYRH INTEGRATED MEMBRANE LUNG

    K Number: K922933 · Decision Nov 30, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    20
    Review Days
    165

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    Basic Information

    Device Name
    SORIN MONOLYRH INTEGRATED MEMBRANE LUNG
    K Number
    K922933
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sorin Biomedica, Fiat, USA, Inc.
    Date Received
    June 18, 1992
    Decision Date
    November 30, 1992
    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 Sorin Biomedica, Fiat, USA, Inc.

    K Number Device Name
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    K924354 STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR
    K925541 STOCKERT 1/4 BUBBLE SENSOR
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