MEB-5200

FDA 510(k) K854664 · Nihon Kohden America, Inc.

Substantially Equivalent

510(k) numberK854664

Submission

Device name
MEB-5200
Applicant
Nihon Kohden America, Inc.
Irvine, CA, US
Received
November 20, 1985
Decision date
August 14, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IKT – Electrode, Needle, Diagnostic Electromyograph
Device class
Class II (moderate risk)
Regulation
21 CFR 890.1385
Specialty
Physical Medicine

Other 510(k)s with product code IKT

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K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable…IKT · Traditional Technomed Europe03/15/2026SE
K173815Allergan Botox Needle ElectrodeIKT · Traditional Natus Manufacturing Limited06/29/2018SE
K161430Myoject Luer Lock Needle ElectrodeIKT · Traditional Natus Manufacturing Limited03/02/2017SE
K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes…IKT · Traditional Bio Protech, Inc.06/03/2016SE
K143433Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable…IKT · Traditional Natus Manufacturing Limited08/28/2015SE
K120342Emg Recording Electrode AssemblyIKT · Traditional Rhythmlink International, LLC06/22/2012SE
K112034Teca Elite Disposable Concentric NeedlesIKT · Special Carefusion 209, Inc.08/12/2011SE
K111131Teca (TM) Elite Disposable Monopolar NeedlesIKT · Special Carefusion 209, Inc.06/17/2011SE
K092973Disposable and Reusable Concentric Needles / Disposable and Reusable Monopolar NeedleIKT · Traditional Bionen S.A.S.10/07/2010SE
K093825Ambu Neuroline Disposable Inoject Needle ElectrodeIKT · Special Ambu A/S01/13/2010SE

More from Ambu A/S

510(k)DeviceDecision
K113117Nihon Kohden EEG-1200A with JE-120A Multi Channel Electrode Junction BoxGWQ · Special 03/22/2012SE
K120485Nihon Kohden QP-160 Ak Trend Program with the Addition of Dsa Asymmetry Trend and FFT POMA · Special 03/16/2012SE
K092573Nihon Kohden QP-160AK EEG Trend ProgramOMA · Traditional 07/09/2010SE
K083456Nihon Kohden CO2 Sensor Kit, Model TG-970PCCK · Special 03/02/2009SE
K083271BSM-2300 &BSM6000 with CGS-9001 Series Communication Gateway, Model CGS-9001 Series…MHX · Special 12/24/2008SE
K082785Nihon Kohden Bedside Monitor, BSM 9100A SeriesMHX · Special 11/26/2008SE
K071969SEN-4100 Electric StimulatorGWF · Traditional 10/06/2008SE
K080546Nihon Kohden EEG-1200A Series Neurofax, Model EEG-1200AOLT · Special 08/29/2008SE
K073550Prefense EDNS-9000 Series Nurse Central StationMHX · Special 03/28/2008SE
K080342Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesMHX · Special 02/26/2008SE

Questions and answers

When was MEB-5200 cleared by the FDA?

MEB-5200 (K854664) received a 510(k) decision of Substantially Equivalent on August 14, 1986, 267 days after the submission was received.

What is the product code of K854664?

The FDA product code is IKT – Electrode, Needle, Diagnostic Electromyograph, a Class II (moderate risk) device regulated under 21 CFR 890.1385.