BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NOBLES-LAI VIDEO IMAGING SYSTEM

    K Number: K940273 · Decision May 22, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    92
    Applicant Total
    1
    Review Days
    486

    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
    NOBLES-LAI VIDEO IMAGING SYSTEM
    K Number
    K940273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1480
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Visioneering, Inc.
    Date Received
    January 21, 1994
    Decision Date
    May 22, 1995
    Product Code
    GWG
    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
    GWG Endoscope, Neurological

    Similar 510(k) Clearances

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

    Precision S 4K Sinuscope

    FDA 510(k)
    FDA Class 2 ·Neurology

    Hydro Irrigation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    HJY VisualNext 3D Endoscopic Vision System

    FDA 510(k)
    FDA Class 2 ·Neurology

    AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)

    FDA 510(k)
    FDA Class 2 ·Neurology

    cCeLL - In vivo

    FDA 510(k)
    FDA Class 2 ·Neurology

    Digital ClarusScope System, Digital NeuroPEN System

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