Atlas FDA

OMC

29 FDA 510(k) clearances · Product code

90 daysmedian time to decision
396 days90th percentile
29clearances measured

FDA profile

Official device name
Reduced- Montage Standard Electroencephalograph
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1400
Medical specialty
Neurology
Flags
Third-party review eligible
FDA definition
Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes
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RecordFirmDate
Ceribell Monitor (K261101)Ceribell, Inc.2026-06-30
NX01 (NX01) (K251550)Naox Technologies Sas2025-11-25
SignalNED System (Model RE) (K251726)Forest Devices, Inc.2025-09-03
REMI Remote EEG Monitoring System (K243185)Epitel2025-03-21
Natus BrainWatch System (K242930)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2024-11-19
QUEX ED; QUEX S (K232779)Qx World, Ltd.2024-10-11
SignalNED System (Model RE) (K242306)Forest Devices, Inc.2024-09-04
REMI Remote EEG Monitoring System (K230933)Epitel, Inc.2023-06-30
NEBA® Compact EEG2R Mobile Headset (K223628)Neba Health, LLC2023-03-02
Neurosteer EEG Recorder (K221563)Neurosteer, Inc.2022-10-24
REMI (K203827)Epitel, Inc.2021-03-29
Byteflies Kit (K192549)Byteflies NV2020-06-22
AE-120A EEG Head Set (K183529)Nihon Kohden Corporation2019-03-19
Ceribell Pocket EEG Device (K170363)Ceribell, Inc.2017-05-08
X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) (K152040)Advanced Brain Monitoring, Inc.2015-10-30
IEEG (K131944)Jordan Neuroscience, Inc.2014-04-10
X4 SYSTEM (K130013)Advanced Brain Monitoring, Inc.2013-01-31
X4 (K120447)Advanced Brain Monitoring, Inc.2012-06-20
ENTERPRISE ELECTROPHYSIOLOGY SYSTEM (K110967)Neuralynx, Inc.2011-06-30
NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 (K092477)Neurowave Systems, Inc.2010-10-29
NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM (K060523)Cyberkinetics, Inc.2006-03-28
BIOSOMNIA-V3 (K042309)Oxford Biosignals Limited2004-09-08
ENVOY PATIENT MONITOR (K024245)Mennen Medical , Ltd.2004-05-10
BIOSOMNIA (K021485)Oxford Biosignals Limited2002-09-11
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 (K020335)Olympic Medical Corp.2002-06-18
CRYSTAL MONITOR MODEL 16 (K013863)Cleveland Medical Devices, Inc.2002-02-19
CRYSTAL-EEG MODEL 15 (K001110)Cleveland Medical Devices, Inc.2000-07-05
CRYSTAL-EEG MODEL 10 (MODEL 10) (K970672)Cleveland Medical Devices, Inc.1997-05-22
ACCESSORY TO ECG ANALYSIS SYS. (K781130)Oxford Medilog, Inc.1978-08-23

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