BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EnsoETM

    Reg #: 3010412492 · FEI: 3010412492 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Advanced Cooling Therapy, LLC
    Registration Number
    3010412492
    FEI Number
    3010412492
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    125 Summer St
    City
    Boston
    State
    MA
    ZIP
    02110
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172493

    Owner / Operator

    Firm Name
    Advanced Cooling Therapy, LLC d/b/a "Attune Medical"
    Operator Number
    10044486
    Address
    125 Summer St
    City
    Boston
    State
    MA
    Postal Code
    02110
    Country
    US
    Correspondent
    Julie Ryan

    Products

    Device Name Product Code
    Esophageal Thermal Regulation And Gastric Suctioning Device PLA

    Proprietary Names

    EnsoETM

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility