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

    NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG

    K Number: K072362 · Decision Oct 23, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    2
    Review Days
    62

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    Basic Information

    Device Name
    NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG
    K Number
    K072362
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Novalung GmbH
    Date Received
    August 22, 2007
    Decision Date
    October 23, 2007
    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 Novalung GmbH

    K Number Device Name
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