BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Aerosure Medic

    Reg #: 3011501130 · FEI: 3011501130 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Actegy Health Inc.
    Registration Number
    3011501130
    FEI Number
    3011501130
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7320 NW 12th Street,, Suite 103 Doral,
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140772

    Owner / Operator

    Firm Name
    Actegy Ltd.
    Operator Number
    10044804
    Address
    West Point, Western Road
    City
    Bracknell
    State
    GB-NOTA
    Postal Code
    RG12 1HJ
    Country
    GB
    Correspondent
    Roseanna Penny

    Products

    Device Name Product Code
    Spirometer, Therapeutic (Incentive) BWF

    Proprietary Names

    Aerosure Medic

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198