GWL

8-CH Electroencephalography Amplifier

Advisory panel: Neurology
Total cleared: 53

Recent clearances under product code GWL

K243746 — Delphi Amplifier Quantalx Neroscience · 2025-03-12
K242832 — NExT Station; NExT Station Advanced Eb Neuro S.P.A. · 2024-12-12
K240646 — DreamClear Somnomed Technologies Inc., Doing Business AS Remware · 2024-09-04
K242305 — BE Plus PRO, Neurotravel LIGHT Eb Neuro S.P.A. · 2024-09-04
K232210 — X-trodes System M X-Trodes · 2024-02-04
K230148 — Vlab Dormotech Medical, Ltd. · 2023-10-11
K223676 — SomniCheck Brainmatterz, LLC · 2023-06-01
K220631 — NomadAir PMU810 Neurotronics, Inc. · 2022-07-15
K203331 — Quick-20m Cgx, LLC · 2021-05-20
K202174 — Digital NeuroPort Biopotential Signal Processing System Blackrock Microsystems · 2021-02-10
K201747 — 8-CH Electroencephalography Amplifier Hipposcreen Neurotech Corp. · 2020-12-27
K172312 — eego amplifiers Eemagine Medical Imaging Solutions GmbH · 2018-03-30
K171397 — Sienna Ultimate Wireless Amplifier Ems Handels Gesellschaft M.B.H. · 2017-10-06
K171669 — g.Nautilus PRO G.Tec Medical Engineering GmbH · 2017-07-05
K151600 — R-40 EEG Amplifier Lifelines , Ltd. · 2015-10-23
K133517 — NEMUS 2 SYSTEM Eb Neuro S.P.A. · 2014-02-26
K123255 — g.HIamp G.Tec Medical Engineering GmbH · 2012-12-20
K121996 — BE PLUS LTM AMPLIFIER GWI AMPLIFIER Eb Neuro S.P.A. · 2012-08-03
K103140 — NICOLET WIRELESS EEG Carefusion 209, Inc. · 2011-04-08
K092699 — NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 Neurotronics, Inc. · 2010-03-18
K090957 — BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM I2s Micro Implantable Systems, LLC · 2009-05-28
K083322 — NEUROMETRIX BIOAMPLIFIER Neurometrix, Inc. · 2009-05-27
K063599 — PORTI 7 PHYSIOLOGICAL AMPLIFIER Tms International BV · 2007-03-22
K060374 — REFA, PHYSIOLOGICAL AMPLIFIER Tms International BV · 2006-05-30
K060803 — G.USBAMP G.Tec Medical Engineering GmbH · 2006-05-02
K053606 — BE PLUS / AURA-LTM64 AMPLIFIER Eb Neuro S.P.A. · 2006-01-24
K051852 — SINGLE AMPLIFIER FOR BOTOX Allergan, Inc. · 2005-09-14
K052060 — OPTI-AMP DC-POWERED Intelligent Hearing Systems · 2005-08-31
K041198 — NIC36 AMPLIFIER Eb Neuro S.P.A. · 2004-06-01
K040113 — SANDMAN SD20 AMPLIFIER Eb Neuro S.P.A. · 2004-02-18
K003154 — MIZAR, BASIS BE, SANDMAN DIGITAL Eb Neuro S.P.A. · 2001-01-05
K972515 — SENSOR AMPLIFIER Pro-Tech Services, Inc. · 1997-10-02
K963669 — GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM Astro-Med, Inc. · 1996-12-12
K943673 — MMC AMPLIFIER Melville Software , Ltd. · 1994-10-26
K914876 — OPTI-AMP Intelligent Hearing Systems · 1992-01-10
K912436 — AM-PAK Cns, Inc. · 1991-10-18
K901797 — THE WONDER BOX Micro Tronics Corp. · 1991-02-07
K904222 — VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER Telediagnostic Systems, Inc. · 1991-01-18
K900063 — MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA) Bio-Feedback Systems, Inc. · 1990-02-16
K884071 — AMPLAID EMG15 Amplus Corp. · 1989-02-27
K881177 — MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD Nihon Kohden America, Inc. · 1988-09-30
K880773 — THE VENUS SYSTEM Neuroscientific Corp. · 1988-08-18
K870794 — MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER Nihon Kohden America, Inc. · 1987-09-30
K871678 — NICOLET AMP 6R11 SYSTEM Nicolet Biomedical Instruments · 1987-07-16
K860289 — PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER Professional Health Technologies, Inc. · 1986-08-25
K861014 — AMPLAID MK15 (EVOKED POTENTIAL SYSTEM) Amplaid USA, Inc. · 1986-08-20
K841612 — NEUROPACK II 5100 Nihon Kohden America, Inc. · 1984-06-07
K833413 — COMPUTERSCOPE CPS-ABR Rc Electronics, Inc. · 1983-11-28
K821250 — METRACO EVOKED POTENTIAL SYSTEM Metraco, Inc. · 1982-07-02
K781743 — RESPONSE SYSTEM, TN-3000 Tracor Instruments, Inc. · 1978-12-01
K781289 — PREAMPLIFIER MODEL 113 Princeton Applied Research Corp. · 1978-09-14
K772102 — AMPLIFIER OTRONA, MODEL N3A-EMG Honeywell, Inc. · 1977-11-21
K771683 — AMPLIFIER MODEL N3B-EEG Honeywell, Inc. · 1977-09-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.