BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    ISEN-Goggles

    K Number: K152727 · Decision Apr 26, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    58
    Applicant Total
    1
    Review Days
    217

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ISEN-Goggles
    K Number
    K152727
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Isen Tech & Trading Company, Ltd.
    Date Received
    September 22, 2015
    Decision Date
    April 26, 2016
    Product Code
    GWN
    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
    GWN Nystagmograph

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GWN), ordered by most recent decision date.

    NeuroEars-Anna™

    FDA 510(k)
    FDA Class 2 ·Neurology

    ICS Dizcovery (1091)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Synapsys VHIT

    FDA 510(k)
    FDA Class 2 ·Neurology

    NeuroSwift Pro

    FDA 510(k)
    FDA Class 2 ·Neurology

    Insight Infrared Video Goggles

    FDA 510(k)
    FDA Class 2 ·Neurology

    VisualEyes

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all