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 |