BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Exsufflation Belt

    Reg #: 3025936435 · FEI: 3025936435 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    LUNG ASSIST II INC
    Registration Number
    3025936435
    FEI Number
    3025936435
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4655 KIRKWOOD COURT
    City
    Boulder
    State
    CO
    ZIP
    80301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K800999

    Owner / Operator

    Firm Name
    Lung Assist II Inc
    Operator Number
    10087122
    Address
    4655 KIRKWOOD COURT
    City
    Boulder
    State
    CO
    Postal Code
    80301
    Country
    US
    Correspondent
    LEWIS W WARD

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK

    Proprietary Names

    Exsufflation Belt

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility