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 |
| K230148 | DormoTech Medical Ltd. | Vlab | 10/11/2023 |
| K242305 | EB Neuro S.p.A. | BE Plus PRO, Neurotravel LIGHT | 09/04/2024 |
| K242832 | EB Neuro S.p.A. | NExT Station; NExT Station Advanced | 12/12/2024 |
| 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 |
| K243746 | QuantalX Neroscience | Delphi Amplifier | 03/12/2025 |
| K240646 | SomnoMed Technologies Inc., doing business as REMware | DreamClear | 09/04/2024 |
| K063599 | TMS INTERNATIONAL BV | PORTI 7 PHYSIOLOGICAL AMPLIFIER | 03/22/2007 |
| K060374 | TMS INTERNATIONAL BV | REFA, PHYSIOLOGICAL AMPLIFIER | 05/30/2006 |
| K232210 | X-Trodes | X-trodes System M | 02/04/2024 |
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