BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Mistral-Air

    Reg #: 1055823 · FEI: 1000111140 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ADROIT MEDICAL SYSTEMS, INC.
    Registration Number
    1055823
    FEI Number
    1000111140
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1146 CARDING MACHINE RD.
    City
    LOUDON
    State
    TN
    ZIP
    37774
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101705

    Owner / Operator

    Firm Name
    ADROIT MEDICAL SYSTEMS, INC.
    Operator Number
    9005173
    Address
    1146 CARDING MACHINE RD., --
    City
    Loudon
    State
    TN
    Postal Code
    37774
    Country
    US
    Correspondent
    KELLEY - PATTEN

    Products

    Device Name Product Code
    System, Thermal Regulating DWJ

    Proprietary Names

    Mistral-Air

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)