BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PULMONE USA INC

    Reg #: 3011583549 · FEI: 3011583549 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    PULMONE USA INC
    Registration Number
    3011583549
    FEI Number
    3011583549
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4100 Medical Pkwy Ste 200
    City
    Carrollton
    State
    TX
    ZIP
    75007
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161295

    Owner / Operator

    Firm Name
    PulmOne USA INC
    Operator Number
    10049302
    Address
    3740 N. Josey Lane, Suite 244
    City
    Carrollton
    State
    TX
    Postal Code
    75007
    Country
    US

    Products

    Device Name Product Code
    Spirometer, Diagnostic BZG
    Calculator, Pulmonary Function Data BZC

    Proprietary Names

    MiniBox+

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility