FDA 510(k) Applications for Medical Device Product Code "GWL"
(Amplifier, Physiological Signal)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K051852 |
ALLERGAN, INC. |
SINGLE AMPLIFIER FOR BOTOX |
09/14/2005 |
K963669 |
ASTRO-MED, INC. |
GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM |
12/12/1996 |
K202174 |
Blackrock Microsystems |
Digital NeuroPort Biopotential Signal Processing System |
02/10/2021 |
K223676 |
BrainMatterZ, LLC |
SomniCheck |
06/01/2023 |
K103140 |
CAREFUSION 209, INC. |
NICOLET WIRELESS EEG |
04/08/2011 |
K203331 |
CGX, LLC |
Quick-20m |
05/20/2021 |
K053606 |
EB NEURO, S.P.A. |
BE PLUS / AURA-LTM64 AMPLIFIER |
01/24/2006 |
K121996 |
EB NEURO, S.P.A. |
BE PLUS LTM AMPLIFIER GWI AMPLIFIER |
08/03/2012 |
K003154 |
EB NEURO, S.P.A. |
MIZAR, BASIS BE, SANDMAN DIGITAL |
01/05/2001 |
K133517 |
EB NEURO, S.P.A. |
NEMUS 2 SYSTEM |
02/26/2014 |
K041198 |
EB NEURO, S.P.A. |
NIC36 AMPLIFIER |
06/01/2004 |
K040113 |
EB NEURO, S.P.A. |
SANDMAN SD20 AMPLIFIER |
02/18/2004 |
K172312 |
eemagine Medical Imaging Solutions GmbH |
eego amplifiers |
03/30/2018 |
K171397 |
EMS Handels Gesellschaft m.b.H. |
Sienna Ultimate Wireless Amplifier |
10/06/2017 |
K123255 |
G.TEC MEDICAL ENGINEERING GMBH |
g.HIamp |
12/20/2012 |
K171669 |
g.tec medical engineering GmbH |
g.Nautilus PRO |
07/05/2017 |
K060803 |
G.TEC MEDICAL ENGINEERING GMBH |
G.USBAMP |
05/02/2006 |
K201747 |
HippoScreen Neurotech Corp. |
8-CH Electroencephalography Amplifier |
12/27/2020 |
K090957 |
I2S MICRO IMPLANTABLE SYSTEMS, LLC |
BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM |
05/28/2009 |
K052060 |
INTELLIGENT HEARING SYSTEMS |
OPTI-AMP DC-POWERED |
08/31/2005 |
K151600 |
LIFELINES LTD. |
R-40 EEG Amplifier |
10/23/2015 |
K083322 |
NEUROMETRIX, INC. |
NEUROMETRIX BIOAMPLIFIER |
05/27/2009 |
K092699 |
NEUROTRONICS, INC. |
NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 |
03/18/2010 |
K220631 |
Neurotronics, Inc. |
NomadAir PMU810 |
07/15/2022 |
K972515 |
PRO-TECH SERVICES, INC. |
SENSOR AMPLIFIER |
10/02/1997 |
K063599 |
TMS INTERNATIONAL BV |
PORTI 7 PHYSIOLOGICAL AMPLIFIER |
03/22/2007 |
K060374 |
TMS INTERNATIONAL BV |
REFA, PHYSIOLOGICAL AMPLIFIER |
05/30/2006 |
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