BEUDAMED
    FDA Registration Active 🇺🇸 United States

    B4C System - Wireless Sensor Headband (Model: BcAc-AF-2000)

    Reg #: 3023074935 · FEI: 3023074935 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Braincare USA Corp.
    Registration Number
    3023074935
    FEI Number
    3023074935
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6470 E Johns Crossing, Suite 160 Office 114
    City
    Johns Creek
    State
    GA
    ZIP
    30097
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240821

    Owner / Operator

    Firm Name
    Braincare Desenvolvimento e Inovacao Tecnologica S.A.
    Operator Number
    10061705
    Address
    Av Bruno Ruggiero Filho, 971
    City
    São Carlos
    State
    Sao Paulo
    Postal Code
    13562-420
    Country
    BR

    Products

    Device Name Product Code
    Device, Monitoring, Intracranial Pressure GWM

    Proprietary Names

    B4C System - Wireless Sensor Headband (Model: BcAc-AF-2000) B4C System - Wireless Sensor (Model: BCSs-PICNIW-2000) B4C System - Wireless Adapter (Model: BcAc-DG-1000) B4C System B4C System - Addition of new sensor model (BcSs-PICNIW-2000) B4C System - Wireless Sensor Charger (Model: BcAc-DCK-2000) B4C System - Plastic casing (Model: BcAc-CASE-2000)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198