g.Nautilus PRO 5120PRO

GUDID EBCI5120PRO0

The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.

g.tec medical engineering GmbH

Multiple physiological signal amplifier

Primary Device ID	EBCI5120PRO0
NIH Device Record Key	36674198-a40b-4ad0-b0d5-26e383cc0d6c
Commercial Distribution Status	In Commercial Distribution
Brand Name	g.Nautilus PRO
Version Model Number	8-Channel
Catalog Number	5120PRO
Company DUNS	300916041
Company Name	g.tec medical engineering GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+437251222400
Email	support@gtec.at
Phone	+437251222400
Email	support@gtec.at
Phone	+437251222400
Email	support@gtec.at
Phone	+437251222400
Email	support@gtec.at
Phone	+437251222400
Email	support@gtec.at
Phone	+437251222400
Email	support@gtec.at
Phone	+437251222400
Email	support@gtec.at
Phone	+437251222400
Email	support@gtec.at
Phone	+437251222400
Email	support@gtec.at
Phone	+437251222400
Email	support@gtec.at
Phone	+437251222400
Email	support@gtec.at
Phone	+437251222400
Email	support@gtec.at
Phone	+437251222400
Email	support@gtec.at
Phone	+437251222400
Email	support@gtec.at

Device Dimensions

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Device Size Text, specify	0
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Device Size Text, specify	0

Operating and Storage Conditions

Storage Environment Humidity	Between 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 25 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBCI5120PRO0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K171669

FDA Product Code

GWL	Amplifier, Physiological Signal

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2017-11-23

On-Brand Devices [g.Nautilus PRO]

EBCI5220PRO0	The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5212PRO0	The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5211PRO0	The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5210PRO0	The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5201PRO0	The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5200PRO0	The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5120PRO0	The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5112PRO0	The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5111PRO0	The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5110PRO0	The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5101PRO0	The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5100PRO0	The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5720PRO0	The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5710PRO0	The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5700PRO0	The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit
EBCI5730PRO0	The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit