FDA.reportPublic FDA data

Neurovirtual

Primary DI
00867975000226
Brand
Neurovirtual
Company
M F Equipamentos Medicos Ltda Epp
Model
BWIII PSG
Catalog number
PV 2008
Device description
BWIII PSG: Full-montage standard electroencephalograph device
Published
2016-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph
OLVStandard Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2
OLVStandard Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112107000BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUSNeurovirtual USA, Inc.2011-10-28GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00867975000226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00867975000226008679750002268679750002260867975000226

GMDN Terms#

Term, Definition table
TermDefinition
PolysomnographA mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal102 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal102 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
904571309
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00867975000202NeurovirtualBWIII PSG PlusPV 20092016-04-15
00867975000219NeurovirtualBWIII EEG PlusPV 20072016-04-15
00867975000233NeurovirtualBWIII EEGPV 20062016-04-15
00867975000240NeurovirtualBWII EEG DigitalPV 16522016-04-15
00867975000257NeurovirtualBWII PSG DigitalPV 18252016-04-15
00867975000264NeurovirtualBWMini EEGPV 23102016-04-15
00867975000271NeurovirtualBWMini HSTPV 23122016-04-15
00867975000288NeurovirtualBWMini PSGPV 23112016-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063034401Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034418Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034425Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034432Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034449Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034456Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034470Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034487Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034494Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
00850063034524Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLV2026-09-25
18436612824038Enobio DxNEUROELECTRICS BARCELONA SLGWQ2026-09-18
18436612824045Enobio DxNEUROELECTRICS BARCELONA SLGWQ2026-09-18
18436612824052Enobio DxNEUROELECTRICS BARCELONA SLGWQ2026-09-18
00860016073401Evoke EEG SystemFirefly Neuroscience, Inc.GWQ2026-07-07
00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWQ2026-07-07
04250413405725HomeSleepTestSOMNOmedics AGOLV2026-07-02
04250413405732HomeSleepTest REM+SOMNOmedics AGOLV2026-07-02
08720256698296Onera STS 2Onera B.V.OLV2026-05-15
08720256698302Onera STS 2Onera B.V.OLV2026-05-15
08720256698319Onera STS 2Onera B.V.OLV2026-05-15
08720256698326Onera STS 2Onera B.V.OLV2026-05-15
08720256698333Onera STS 2Onera B.V.OLV2026-05-15
08720256698340Onera STS 2Onera B.V.OLV2026-05-15
08720256698357Onera STS 2Onera B.V.OLV2026-05-15
08720256698364Onera STS 2Onera B.V.OLV2026-05-15
08720256698371Onera STS 2Onera B.V.OLV2026-05-15
08720256698463Onera STSOnera B.V.OLV2026-05-15
08720256698487Onera STSOnera B.V.OLV2026-05-15
08720256698494Onera STSOnera B.V.OLV2026-05-15
08720256698500Onera STSOnera B.V.OLV2026-05-15