BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Athlos-Air

    Reg #: 3020117925 · FEI: 3020117925 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ATHLOS OY
    Registration Number
    3020117925
    FEI Number
    3020117925
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Klovinpellontie 1-3
    City
    Espoo Uusimaa
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K211688

    Owner / Operator

    Firm Name
    Athlos Oy
    Operator Number
    10082517
    Address
    Klovinpellontie 1-3
    City
    Espoo
    State
    Uusimaa
    Postal Code
    02180
    Country
    FI
    Correspondent
    Konstantinos Spartiotis

    US Agent

    Business Name
    Freedom Technologies Group LLC
    Contact Name
    Robert Sachs
    Address
    4321 Goshen Rd
    City
    Fort Wayne
    State
    IN
    ZIP
    46818
    Country
    US
    Email
    [email protected]
    Phone
    248 7605611

    Products

    Device Name Product Code
    System, X-Ray, Extraoral Source, Digital MUH

    Proprietary Names

    Athlos-Air Athlos-1 DC-Air™

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device