BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    SAPPHIRE PREMIERE

    K Number: K923303 · Decision Nov 24, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    137
    Applicant Total
    8
    Review Days
    141

    Basic Information

    Device Name
    SAPPHIRE PREMIERE
    K Number
    K923303
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    MEDELEC LTD.
    Date Received
    July 6, 1992
    Decision Date
    November 24, 1992
    Product Code
    GWF
    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
    GWF Stimulator, Electrical, Evoked Response

    Similar 510(k) Clearances

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

    Nicolet EDX

    FDA 510(k)
    FDA Class 2 ·Neurology

    Natus Ultrapro S100 (982A0594)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Delphi Stimulator

    FDA 510(k)
    FDA Class 2 ·Neurology

    SafeOp 3: Neural Informatix Systeem

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)

    FDA 510(k)
    FDA Class 2 ·Neurology

    ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress

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

    Other Clearances by MEDELEC LTD.

    K Number Device Name
    K965065 TECA. MILLENNIUM
    K964280 DG NERVUS
    K954157 DG PORTABLE SYSTEM
    K953799 DG EXAMINER PLUS
    K953732 TECA PREMIERE
    K934670 DG 3P SYSTEM
    K934669 ARC