FDA.reportPublic FDA data

Discovery

Primary DI
00852391007041
Brand
Discovery
Company
BRAINMASTER TECHNOLOGIES, INC.
Model
Discovery 20
Catalog number
390-070
Device description
EEG Amplifier
Published
2023-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150498000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150498000Discovery 24Brainmaster Technologies, Inc.2016-01-26GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852391007041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852391007041008523910070418523910070410852391007041

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographAn electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440 232-6000support@brainm.com

Regulatory Flags#

DUNS number
008607256
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852391007003AtlantisAtlantis II 2x2390-0402023-08-15
00852391007010DiscoveryDiscovery 24390-0602023-08-15
00852391007027AtlantisAtlantis 4x4390-0302023-08-15
00852391007034AtlantisAtlantis 2eb+390-0252023-08-15

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Primary DI, Brand, Company table
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08056446900918BE PLUS PRO FULLEB NEURO SPAGWQ2024-12-04
08056446900925BE PLUS PRO ADVANCEDEB NEURO SPAGWQ2024-12-04
08056446900932BE PLUS PRO Battery PackEB NEURO SPAGWQ2024-12-04
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08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAGWQ2024-12-04
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