BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MACS CPAP System

    Reg #: 3003697063 · FEI: 3003697063 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    AIRON CORPORATION
    Registration Number
    3003697063
    FEI Number
    3003697063
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    751 North Dr Unit 6
    City
    Melbourne
    State
    FL
    ZIP
    32934
    Country
    US

    Regulatory Submissions

    510(k) Number
    K080692

    Owner / Operator

    Firm Name
    AIRON CORPORATION
    Operator Number
    9051096
    Address
    751 North Drive, Unit 6, --
    City
    Melbourne
    State
    FL
    Postal Code
    32934
    Country
    US
    Correspondent
    Emilia Castellucci

    Products

    Device Name Product Code
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Ventilator, Emergency, Powered (Resuscitator) BTL

    Proprietary Names

    MACS CPAP System

    Establishment Types

    Manufacture Medical Device