FDA.reportPublic FDA data

g.Nautilus PRO

Primary DI
EBCI5112PRO0
Brand
g.Nautilus PRO
Company
g.tec medical engineering GmbH
Model
16-Channel-rX
Catalog number
5112PRO
Device description
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
Published
2017-11-23
Public version status
Update
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
EBCI5112PRO0PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity25 Percent (%) Relative Humidity65 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
EBCI80600cortiQ PROTD 1.x2020-03-06
EBCI5730PRO0g.Nautilus PRO19 FLEXIBLE channels5730PRO2024-05-28
EBCI11700g.Estim FESTD 1.x11702020-12-01
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
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

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