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)
Top companies in GWQ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2026 | Micromed 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 |
GWQ | K171384 |
| Jul 18, 2025 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph Open, Classified |
GWQ | K180290 |
| Sep 13, 2024 | SEER 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 |
GWQ | K212788 |
| May 31, 2024 | WAVi 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 |
GWQ | None listed |
| Jan 14, 2021 | Nihon 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 |
GWQ | K120888 |
| Oct 11, 2019 | LIFELINES 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 |
GWQ | K170441 |
| Oct 11, 2019 | LIFELINES 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 |
GWQ | K170441 |
| May 15, 2018 | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) XLTEK EMU40EX EEG Headbox Terminated |
GWQ | None listed |
| Nov 11, 2015 | Natus 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 |
GWQ | K143440 |
| Oct 13, 2015 | Natus 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 |
GWQ | K964280 |
| Apr 22, 2013 | Stellate 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 |
GWQ | K010728 K083577 |
| Jan 11, 2012 | Stellate 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 |
GWQ | None listed |
| Apr 7, 2010 | CareFusion NicoletOne vEEG System, VIASYS Healthcare, Inc., Madison, Wisconsin 53711. Terminated |
GWQ | K991054 |
| Sep 23, 2008 | Cardinal 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 |
GWQ | K991054 |
| Sep 21, 2008 | Cardinal Health NeuroCare Division NicoletOne photic adapter cable 085-463700 Terminated |
GWQ | K991054 |
| Apr 24, 2008 | Respironics, 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 |
GWQ | K040595 K982454 |
| Jan 3, 2008 | Nicolet 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 |
GWQ | K021185 |
| Nov 3, 2007 | Bio-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 |
GWQ | K052066 |
| Sep 20, 2007 | Nicolet 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 |
GWQ | K891405 |
| Apr 20, 2007 | Bio-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 |
GWQ | K052066 |
| Feb 15, 2007 | Nicolet 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 |
GWQ | K991054 |
| Mar 24, 2005 | Compumedics Usa, Ltd Nonin Xpod Oximeter model numbers 3011 and 3012, distributed for use with the Compumedics E-Series Digital Amplifier. Terminated |
GWQ | None listed |
| Mar 24, 2005 | Compumedics Usa, Ltd Compumedics E-Series Digital Amplifier System part number 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia Terminated |
GWQ | K000068 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.