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Panels › Neurology › Product code GWQ · Class 2

Full-Montage Standard Electroencephalograph

Regulation 882.1400

2510(k)s in 12 months (189 all time)
1recalls in 12 months (23 all time)
19recalls that name a 510(k)
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Top companies in GWQ

DateFirm and productCodeLinked 510(k)
Jun 5, 2026Micromed S.p.A.
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
Open, Classified
GWQK171384
Jul 18, 2025Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Open, Classified
GWQK180290
Sep 13, 2024SEER MEDICAL PTY LTD
Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Mon
Open, Classified
GWQK212788
May 31, 2024WAVi Co.
WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart Rate Variability (HRV) Ear Clips. The system kit also incorporat
Open, Classified
GWQNone listed
Jan 14, 2021Nihon Kohden America Inc
PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a di
Open, Classified
GWQK120888
Oct 11, 2019LIFELINES NEURO COMPANY
ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of
Terminated
GWQK170441
Oct 11, 2019LIFELINES NEURO COMPANY
ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a pa
Terminated
GWQK170441
May 15, 2018Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
XLTEK EMU40EX EEG Headbox
Terminated
GWQNone listed
Nov 11, 2015Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive el
Terminated
GWQK143440
Oct 13, 2015Natus Neurology Inc
NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purp
Terminated
GWQK964280
Apr 22, 2013Stellate Systems
Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring S
Terminated
GWQK010728
K083577
Jan 11, 2012Stellate Systems
Harmonie software in use with: Harmonie-E Long Term Monitoring System (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC-LT2; HSYS-REC-EAMP) Harmonie-S Sleep System (Model HSYS-REC-DUO) VITA/ICU Neurological
Terminated
GWQNone listed
Apr 7, 2010CareFusion
NicoletOne vEEG System, VIASYS Healthcare, Inc., Madison, Wisconsin 53711.
Terminated
GWQK991054
Sep 23, 2008Cardinal Health NeuroCare Division
NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The product is used for extended monitoring of EEG in a hospital setting. The s
Terminated
GWQK991054
Sep 21, 2008Cardinal Health NeuroCare Division
NicoletOne photic adapter cable 085-463700
Terminated
GWQK991054
Apr 24, 2008Respironics, Inc.
Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electrodes model number 1016360; b) O2 Enrichment Attachment BX 10 model number 312010; c) O2 Enrichment Attachment
Terminated
GWQK040595
K982454
Jan 3, 2008Nicolet Biomedical Div of Viasys Healthcare
Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC computer system), released and installed between December 2004 and March 2007 (Axiomtek Panel PC
Terminated
GWQK021185
Nov 3, 2007Bio-Logic Systems Corp
Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model
Terminated
GWQK052066
Sep 20, 2007Nicolet Biomedical Div of Viasys Healthcare
BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during electroencephalography (EEG) /Epilepsy Monitoring evaluations with various EEG monitoring systems. The MicroJac
Terminated
GWQK891405
Apr 20, 2007Bio-Logic Systems Corp
Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Bio-logic Systems Corp., a nebus company, Mundelein, IL 60060; Model 580-T2ASM2. (a Digital EEG/Sleep Recorder Electroencephalograph that includes a bui
Terminated
GWQK052066
Feb 15, 2007Nicolet Biomedical Div of Viasys Healthcare
NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne LTM, Sleep, nEEG, vEEG and ICU monitoring Systems.
Terminated
GWQK991054
Mar 24, 2005Compumedics Usa, Ltd
Nonin Xpod Oximeter model numbers 3011 and 3012, distributed for use with the Compumedics E-Series Digital Amplifier.
Terminated
GWQNone listed
Mar 24, 2005Compumedics Usa, Ltd
Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia
Terminated
GWQK000068

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