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

    ENFANTTM

    K Number: K043491 · Decision Mar 16, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    48
    Applicant Total
    2
    Review Days
    89

    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
    ENFANTTM
    K Number
    K043491
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diopsys, Inc.
    Date Received
    December 17, 2004
    Decision Date
    March 16, 2005
    Product Code
    GWE
    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
    GWE Stimulator, Photic, Evoked Response

    Similar 510(k) Clearances

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

    E3 and Profile

    FDA 510(k)
    FDA Class 2 ·Neurology

    Vision Monitor- MonCvONE

    FDA 510(k)
    FDA Class 2 ·Neurology

    LED PHOTIC System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Vision Monitor - MonpackONE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Nurochek System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Natus Photic Stimulator

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

    Other Clearances by Diopsys, Inc.

    K Number Device Name
    K101763 DIOPSYS NOVA VEP VISION TESTING SYSTEM