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

    Hemolung Respiratory Assist System

    K Number: DEN210006 · Decision Nov 13, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    254

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    Basic Information

    Device Name
    Hemolung Respiratory Assist System
    K Number
    DEN210006
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.4150
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Alung Technologies, Inc.
    Date Received
    March 4, 2021
    Decision Date
    November 13, 2021
    Product Code
    QOH
    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
    QOH Extracorporeal System For Carbon Dioxide Removal