FDA.reportPublic FDA data

g.Nautilus PRO

Primary DI
EBCI5730PRO0
Brand
g.Nautilus PRO
Company
g.tec medical engineering GmbH
Model
19 FLEXIBLE channels
Catalog number
5730PRO
Device description
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
Published
2024-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWLAmplifier, Physiological Signal
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWLAmplifier, Physiological SignalNeurology2
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171669000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171669000g.Nautilus PROG.Tec Medical Engineering GmbH2017-07-05GWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBCI5730PRO0PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity25 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+437251222400support@gtec.at

Regulatory Flags#

DUNS number
300916041
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EBCI11700g.Estim FESTD 1.x11702020-12-01
EBCI80600cortiQ PROTD 1.x2020-03-06
EBCI5700PRO0g.Nautilus PRO32 FLEXIBLE channels5700PRO2021-04-16
EBCI5710PRO0g.Nautilus PRO16 FLEXIBLE channels5710PRO2021-04-16
EBCI5720PRO0g.Nautilus PRO8 FLEXIBLE channels5720PRO2021-04-16
EBCI11500g.Estim PRO111502018-05-30
EBCI5100PRO0g.Nautilus PRO32-Channel5100PRO2017-11-23
EBCI5101PRO0g.Nautilus PRO32-Channel-CSP5101PRO2017-11-23
EBCI5110PRO0g.Nautilus PRO16-Channel5110PRO2017-11-23
EBCI5111PRO0g.Nautilus PRO16-Channel-mB5111PRO2017-11-23
EBCI5112PRO0g.Nautilus PRO16-Channel-rX5112PRO2017-11-23
EBCI5120PRO0g.Nautilus PRO8-Channel5120PRO2017-11-23
EBCI5200PRO0g.Nautilus PRO32-Channel Sahara5200PRO2017-11-23
EBCI5201PRO0g.Nautilus PRO32-Channel-CSP Sahara5201PRO2017-11-23
EBCI5210PRO0g.Nautilus PRO16-Channel Sahara5210PRO2017-11-23
EBCI5211PRO0g.Nautilus PRO16-Channel-mB Sahara5211PRO2017-11-23
EBCI5212PRO0g.Nautilus PRO16-Channel-rX Sahara5212PRO2017-11-23
EBCI5220PRO0g.Nautilus PRO8-Channel Sahara5220PRO2017-11-23
EBCI7001US0g.HIamp80-Channel Amplifier70012017-11-23
EBCI7002US0g.HIamp144-Channel Amplifier70022017-11-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
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00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
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08720791378332Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08