FDA.reportPublic FDA data

HBIdb

Primary DI
04251341900054
Brand
HBIdb
Company
CORSCIENCE GmbH & Co. KG
Model
CS20401
Published
2022-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K112077000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112077000HBIDB - HUMAN BRIAN INDEX SOFTWARECorscience GmbH & Co. KG2012-03-09OLU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251341900054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251341900054042513419000544251341900054

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical signal analysis softwareA software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
333427776
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251341900252COR12CS10785-092023-04-27
04251341900344COR12CS10785-142021-07-01
04251341900108COR12CS10785-012019-11-19
04251341900115COR12CS10785-022019-01-25
04251341900238GoECGCS10785-072019-02-11
04251341900245GoECGCS10785-082019-02-11
04251341900016EEG NeuroAmp IICS101372016-11-14
04251341900023EEG NeuroAmp IICS10137-022017-05-08
04251341900047EEG NeuroAmp IICS102892017-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B592SW100WAVi Scan SoftwareWAVI CO.GWQ2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.GWQ2026-03-25
B592WK200WAVi Scan KitWAVI CO.GWQ2026-03-25
B675PDDU0Zeto ONE Display UnitZETO, INC.GWQ2025-11-19
08690020003062BrainView NeuralScanMedeia, Inc.GWQ2025-02-05
08056446900673Neurotravel LIGHTEB NEURO SPAGWQ2024-12-04
08056446900680Neurotravel LIGHT Base UnitEB NEURO SPAGWQ2024-12-04
08056446900895BE PLUS PRO LIGHTEB NEURO SPAGWQ2024-12-04
08056446900901BE PLUS PRO STANDARDEB NEURO SPAGWQ2024-12-04
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
08056446901311BE PLUS PRO [LIGHT] EB NEURO SPAGWQ2024-12-04
08056446901328BE PLUS PRO [STANDARD]EB NEURO SPAGWQ2024-12-04
08056446901335BE PLUS PRO [FULL]EB NEURO SPAGWQ2024-12-04
08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAGWQ2024-12-04
B675ONEECG1Zeto ONE ECG Cable Extension SetZETO, INC.GWQ2024-06-11
00840067102886Cadwell GuardianCADWELL INDUSTRIES, INC.GWQ2024-03-04
00840067102893Cadwell GuardianCADWELL INDUSTRIES, INC.GWQ2024-03-04
18437017440601Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
18437017440632Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
18437017440663Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
18437017440687Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyGWQ2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyGWQ2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyGWQ2023-04-19
00195278524089NAGE Healthcare Finland OyGWQ2023-04-19
09342451002112SiestaCompumedics Usa, Inc.GWQ2020-12-16
09342451001788SiestaCompumedics Usa, Inc.GWQ2020-12-15
00840067102824Arc EssentiaCADWELL INDUSTRIES, INC.GWQ2020-12-10