BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇷 Brazil

    B4C System

    K Number: K201989 · Decision Oct 8, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    2
    Review Days
    448

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    Basic Information

    Device Name
    B4C System
    K Number
    K201989
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Braincare Desenvolvimento E Inovacao Tecnologica S.A.
    Date Received
    July 17, 2020
    Decision Date
    October 8, 2021
    Product Code
    GWM
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GWM Device, Monitoring, Intracranial Pressure

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    Other Clearances by Braincare Desenvolvimento E Inovacao Tecnologica S.A.

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