BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FERNO2

    Reg #: 2030745 · FEI: 3000204983 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SPIRACLE TECHNOLOGY
    Registration Number
    2030745
    FEI Number
    3000204983
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10601 Calle Lee Ste 190
    City
    Los Alamitos
    State
    CA
    ZIP
    90720
    Country
    US

    Regulatory Submissions

    510(k) Number
    K031434

    Owner / Operator

    Firm Name
    SPIRACLE TECHNOLOGY
    Operator Number
    9026347
    Address
    10601 Calle Lee, Ste 190, --
    City
    Los Alamitos
    State
    CA
    Postal Code
    90720
    Country
    US
    Correspondent
    MICHAEL - SARNE

    Products

    Device Name Product Code
    Ventilator, Emergency, Manual (Resuscitator) BTM

    Proprietary Names

    FERNO2

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility