BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    AcuPebble Ox100

    Reg #: 3024891505 · FEI: 3024891505 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Acurable Limited
    Registration Number
    3024891505
    FEI Number
    3024891505
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Leman Street, London E1W 9US
    City
    London London, City of
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K222950

    Owner / Operator

    Firm Name
    Acurable Limited
    Operator Number
    10086249
    Address
    2 Leman Street, London E1W 9US
    City
    London
    State
    London, City of
    Postal Code
    E1W 9US
    Country
    GB
    Correspondent
    Esther Rodriguez-Villegas

    US Agent

    Business Name
    Dawa Medical LLC
    Contact Name
    Stephan Toupin
    Address
    7320 NW 12th Street, Suite 103, Miami, Florida, 33126, USA
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    786 7211159

    Products

    Device Name Product Code
    Ventilatory Effort Recorder MNR

    Proprietary Names

    AcuPebble Ox100

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device