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

    NEURAL MAGNETIC STIMULATOR, THE D190

    K Number: K883340 · Decision Dec 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    10
    Review Days
    142

    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
    NEURAL MAGNETIC STIMULATOR, THE D190
    K Number
    K883340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Tracor Northern, Inc.
    Date Received
    August 9, 1988
    Decision Date
    December 29, 1988
    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.

    SafeOp 3: Neural Informatix System

    FDA 510(k)
    FDA Class 2 ·Neurology

    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
    View all

    Other Clearances by Tracor Northern, Inc.

    K Number Device Name
    K874733 GUARDIAN, EEG BRAIN MONITORING SYSTEM
    K860968 TM-3400, NOMAD (MODIFIED)
    K860903 TM-3600 A NEURODIAGNOSTIC SYSTEM
    K852587 CDSA(COLOR DENSITY, SPECTRAL ARRRAY)
    K850109 NOMAD TM-3400
    K842964 PHOTIC STIMULATOR TM-3030-70
    K832084 EVOKED 3500 POTENTIAL SYSTEM
    K822396 THE 3500
    K810560 TN-3000 EVOKED RESPONSE SYSTEM