BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Adapter BcAc-MA-1003

    Reg #: 3023074935 · FEI: 3023074935 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    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
    K182073

    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

    Adapter BcAc-MA-1003 Braincare Adapter Cable BcAc-MA-1030 Adapter BcAc-MA-1030 Braincare Wired Sensor Adapter BcAc-MA-1027 Braincare Adapter Cable BcAc-MA-1003 Sensor BcSs-PICNI-2000 BcSs-PICNI-2000 Sensor Braincare BcSs-PICNI- 2000 Sensor Braincare Wired System Headband Set Braincare Adapter Cable BcAc-MA-1027 Adapter BcAc-MA-1028 Braincare Adapter Cable BcAc-MA-1028

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198