FDA 510(k) Applications for Medical Device Product Code "IKN"
(Electromyograph, Diagnostic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K973355 | ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX | ADVANTAGE 3000 | 12/05/1997 |
| K974010 | ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX | ADVANTAGE EMG SYSTEM, MODEL #A100 | 01/16/1998 |
| K023147 | BORTEC BIOMEDICAL, LTD. | ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4 | 12/12/2002 |
| K162383 | CADWELL INDUSTRIES, INC. | Cadwell Sierra Summit, Cadwell Sierra Ascent | 03/01/2017 |
| K131094 | DORSA VI PTY. LTD | VIMOVE | 07/11/2014 |
| K163150 | DORSAVI LTD | ViMove2 | 07/14/2017 |
| K142494 | dorsaVi Ltd. | ViMove | 05/28/2015 |
| K073415 | EB NEURO, S.P.A. | NEMUS SYSTEM; NEMUS PC PERIPHERAL | 05/23/2008 |
| K972419 | ERICH JAEGER, INC. | TOENNIES NEUROSCREEN SYSTEM | 04/30/1998 |
| K052112 | EXCEL TECH. LTD. | XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 | 10/28/2005 |
| K033452 | FASSTECH | CWAS 1000 | 11/28/2003 |
| K063447 | FASSTECH | INSIGHT DISCOVERY | 08/16/2007 |
| K023209 | FASSTECH | INSIGHT MILLENNIUM III | 10/10/2003 |
| K993878 | JACK'S ELECTRODES | JE 2000 | 02/01/2000 |
| K002104 | MARYROSE CUSIMANO, PH.D. & SCOTT ZEFF | COMBINED PHYSIOLOGICAL MONITORING SYSTEM | 10/10/2000 |
| K022719 | MARYROSE CUSIMANO, PH.D./PHIL REASTON | PHYSICAL MONITORING REGISTRATION UNIT | 11/13/2002 |
| K031995 | MEDICAL TECHNOLOGIES UNLIMITED, INC. | COMPREHENSIVE NEUROMUSCULAR PROFILER | 01/07/2004 |
| K113074 | MEDICAL TECHNOLOGIES, INC. | CMAP PRO | 02/02/2012 |
| K024316 | MEDTRONIC XOMED, INC. | NIM-PRS | 01/06/2003 |
| K000220 | MOTION LAB SYSTEMS, INC. | MA-300 ELECTROMYOGRAPHY SYSTEM | 02/24/2000 |
| K974385 | MOTION LAB SYSTEMS, INC. | MLS ELECTROMYOGRAPHIC PREAMPLIFIER | 02/19/1998 |
| K172743 | Natus Neurology Incorporated | Natus VikingQuest | 12/19/2017 |
| K001562 | NEURO SCAN LABS | NEURO SCAN MEDICAL SYSTEMS A4000 | 08/16/2000 |
| K000812 | NEUROSOFT, INC. | NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE) | 05/17/2000 |
| K010590 | NIHON KOHDEN AMERICA, INC. | NEUROPACK MICRO, MODEL MED-9100A SERIES | 06/28/2001 |
| K123902 | OKTX LLC | PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) | 09/13/2013 |
| K984052 | OXFORD INSTRUMENTS MEDICAL SYSTEMS | SYNERGY IOM SYSTEM | 05/17/1999 |
| K990766 | PARASPINAL DIAGNOSTIC CORP. | CERSR ELECTROMYOGRAPHY SYSTEM | 08/27/1999 |
| K123399 | PRECISION BIOMETRICS, INC. | MYOVISION 3.0 WIREFREE SYSTEM | 08/01/2013 |
| K001800 | RJL ASSOCIATES, LLC. | ACCUWARM EMG HEAT LAMP | 09/12/2000 |
| K110048 | SPINEMATRIX, INC. | CERSR ELECTROMYOGRAPHY SYSTEM | 01/26/2011 |
| K102610 | TELEEMG, LLC USA | FOCUS EMG DEVICE | 03/04/2011 |
| K083679 | UROVAL | UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 | 09/11/2009 |
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