IKN · Class II · 21 CFR 890.1375

FDA Product Code IKN: Electromyograph, Diagnostic

Leading manufacturers include Nicolet Biomedical Instruments, Teca, Inc. and Excel Tech. , Ltd..

75
Total
75
Cleared
139d
Avg days
1977
Since

FDA 510(k) Cleared Electromyograph, Diagnostic Devices (Product Code IKN)

75 devices
1–24 of 75
Cleared Dec 19, 2017
Natus VikingQuest
K172743
Natus Neurology Incorporated
Neurology · 98d
Cleared Jul 14, 2017
ViMove2
K163150
Dorsavi, Ltd.
Neurology · 247d
Cleared Mar 01, 2017
Cadwell Sierra Summit, Cadwell Sierra Ascent
K162383
Cadwell Industries, Inc.
Neurology · 188d
Cleared May 28, 2015
ViMove
K142494
Dorsavi, Ltd.
Neurology · 265d
Cleared Jul 11, 2014
VIMOVE
K131094
Dorsa VI Pty., Ltd.
Neurology · 449d
Cleared Sep 13, 2013
PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)
K123902
Oktx, LLC
Neurology · 269d
Cleared Aug 01, 2013
MYOVISION 3.0 WIREFREE SYSTEM
K123399
Precision Biometrics, Inc.
Neurology · 269d
Cleared Feb 02, 2012
CMAP PRO
K113074
Medical Technologies, Inc.
Neurology · 108d
Cleared Jan 26, 2011
CERSR ELECTROMYOGRAPHY SYSTEM
K110048
Spinematrix, Inc.
Neurology · 20d
Cleared Sep 11, 2009
UROVAL BRS SYSTEM, MODEL BRS01
K083679
Uroval
Neurology · 274d
Cleared May 23, 2008
NEMUS SYSTEM
K073415
Eb Neuro S.P.A.
Neurology · 171d
Cleared Aug 16, 2007
INSIGHT DISCOVERY
K063447
Fasstech
Neurology · 274d
Cleared Oct 28, 2005
XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059
K052112
Excel Tech. , Ltd.
Neurology · 85d
Cleared Jan 06, 2003
NIM-PRS
K024316
Medtronic Xomed, Inc.
Neurology · 11d
Cleared Jun 28, 2001
NEUROPACK MICRO, MODEL MED-9100A SERIES
K010590
Nihon Kohden America, Inc.
Neurology · 121d
Cleared Feb 01, 2000
JE 2000
K993878
Jack'S Electrodes
Neurology · 78d
Cleared Aug 27, 1999
CERSR ELECTROMYOGRAPHY SYSTEM
K990766
Paraspinal Diagnostic Corp.
Neurology · 172d
Cleared May 17, 1999
SYNERGY IOM SYSTEM
K984052
Oxford Instruments Medical Systems
Neurology · 185d
Cleared Apr 30, 1998
TOENNIES NEUROSCREEN SYSTEM
K972419
Erich Jaeger, Inc.
Neurology · 307d
Cleared Feb 19, 1998
MLS ELECTROMYOGRAPHIC PREAMPLIFIER
K974385
Motion Lab Systems, Inc.
Neurology · 90d
Cleared Jan 16, 1998
ADVANTAGE EMG SYSTEM, MODEL #A100
K974010
Advantage Medical Division of Cme Telemetrix
Neurology · 87d
Cleared Dec 05, 1997
ADVANTAGE 3000
K973355
Advantage Medical Division of Cme Telemetrix
Neurology · 88d
Cleared Nov 07, 1995
EXCEL EMG
K941144
Excel Tech. , Ltd.
Neurology · 607d
Cleared Jul 02, 1993
NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT
K930328
Bio-Logic Systems Corp.
Neurology · 161d

About Product Code IKN - Regulatory Context