BEUDAMED
    Product Code: GZN FDA class 3 21 CFR 882.1825

    Rheoencephalograph

    Neurology

    The Rheoencephalograph is a neurological diagnostic device that measures electrical impedance changes in the brain related to blood flow pulsations, used historically to assess cerebrovascular circulation. It is classified as a Class 3 device (highest risk), requiring Premarket Approval (PMA); a call for PMAs was issued by December 26, 1996, per 61 FR 50708. The product code is GZN under regulation 21 CFR 882.1825 in the Neurology specialty. No implant or life-sustaining flags apply.

    View on FDA
    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
    —

    Research product code GZN in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    GZN
    Device Class
    FDA class 3
    Regulation Number
    882.1825
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96