BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    MEP Monitor

    K Number: K162873 · Decision Mar 31, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    138
    Applicant Total
    18
    Review Days
    169

    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
    MEP Monitor
    K Number
    K162873
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tonica Elektronik A/S
    Date Received
    October 13, 2016
    Decision Date
    March 31, 2017
    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 Tonica Elektronik A/S

    K Number Device Name
    K260189 MagVenture Accelerated TMS (aTMS) Therapy System
    K251125 MagVenture TMS Therapy System
    K251119 MagVenture TMS Therapy System
    K252032 T65 (9016E061-)
    K230014 MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption
    K221544 MagVenture TMS Atlas Neuro Navigation System
    K193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system
    K173620 Mag Vita TMS Therapy System w/Theta Burst Stimulation
    K172667 MagVita TMS Therapy w/MagPro R20
    K171967 MagVita TMS Therapy System
    Search all 18 clearances from Tonica Elektronik A/S →