BEUDAMED
    FDA Registration Active 🇺🇸 United States

    iTempShield

    Reg #: 3028019184 · FEI: 3028019184 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AION BIOSYSTEMS
    Registration Number
    3028019184
    FEI Number
    3028019184
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    175 Cabot Street, Suite 100
    City
    Lowell
    State
    MA
    ZIP
    01854
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232010

    Owner / Operator

    Firm Name
    AION Biosystems
    Operator Number
    10088613
    Address
    12 Plymouth Rd
    City
    Darien
    State
    CT
    Postal Code
    06820
    Country
    US
    Correspondent
    CARL R SHUBITOWSKI

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL

    Proprietary Names

    iTempShield

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility