FDA.reportPublic FDA data

Q21

Primary DI
00860410000379
Brand
Q21
Company
Neurofield, Inc.
Model
169
Device description
The Q21 is a 19 channel EEG amplifier with a low noise floor of 0.25 microvolts peak to peak from 0.1 to 10.0Hz, meaning that you can record brain wave data without worrying about noise contamination. On top of our low-noise design, the Q21 is a non-multiplexed, multi-channel readout amp, minimizing slew for the most accurate whole brain imaging, and giving you the exact readout of your EEG recordings, with no loss of data or smoothing.
Published
2025-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLTNon-Normalizing Quantitative Electroencephalograph Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221959000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221959000Q21Neurofield, Inc.2023-08-31GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860410000379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860410000379008604100003798604100003790860410000379

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological signal amplifierAn electronic device that increases current, voltage, or power to adjust the signal level and impedance between two or more medical devices transmitting physiological signals; or the device has the capability of being used for more than a single application, such as electroencephalography (EEG), evoked potential, polysomnography (sleep analysis) and general polygraphy.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
948497578
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010064634Genesis1042026-05-07
00860410000300NeuroField X3000172016-08-25
00086041000030NeuroField X3000172016-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyOLT2026-04-15
B592SW100WAVi Scan SoftwareWAVI CO.OLT2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.OLT2026-03-25
B592WK200WAVi Scan KitWAVI CO.OLT2026-03-25
09120109830269encevisAIT Austrian Institute of Technology GmbHOLT2025-08-05
08056446901106NExT-DOCKINGEB NEURO SPAOLT2025-05-22
08056446901113NExT-PADEB NEURO SPAOLT2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAOLT2025-05-22
08056446901137NExT-HSEB NEURO SPAOLT2025-05-22
08056446901168NExT-AMPEB NEURO SPAOLT2025-05-22
08056446901199NExT-ASEB NEURO SPAOLT2025-05-22
08056446901205NExT StationEB NEURO SPAOLT2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAOLT2025-05-19
08690020003062BrainView NeuralScanMedeia, Inc.OLT2025-02-05
08056446900673Neurotravel LIGHTEB NEURO SPAOLT2024-12-04
08056446901311BE PLUS PRO [LIGHT] EB NEURO SPAOLT2024-12-04
08056446901328BE PLUS PRO [STANDARD]EB NEURO SPAOLT2024-12-04
08056446901335BE PLUS PRO [FULL]EB NEURO SPAOLT2024-12-04
08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAOLT2024-12-04
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-11-15
00840067103562Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-11-15
00840067103623Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-11-15
00840067103630Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-11-15
00840067103999CadwellCADWELL INDUSTRIES, INC.OLT2024-08-23
00840067102992Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-08-23
00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.OLT2024-06-21
00817111021264Live View Panel Pro Version 2.0Neurotronics, LLCOLT2024-05-09
10884521808270BISCovidien LPOLT2024-04-28
10884521808300BISCovidien LPOLT2024-04-28