cortiQ PRO 8060

GUDID EBCI80600

cortiQ PRO is a system that uses g.HIamp to map high-gamma broad band brain activity while running an experimental paradigm. The software helps to identify electrode positions coding differences in brain activity by means of experimental paradigm. cortiQ PRO performs the signal analysis in real-time and compares the high-gamma broad band activity during specific tasks. Then it performs a statistical analysis and visualizes electrodes coding the information that are statistically significant. It is abstracted from technical details of data acquisition, channel order and signal processing assuring robust and efficient measurements.

g.tec medical engineering GmbH

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• Primary Device ID: EBCI80600
• NIH Device Record Key: 18d244af-e47c-4f55-88e6-9d4bd5e52aa2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cortiQ PRO
• Version Model Number: TD 1.x
• Catalog Number: 8060
• 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: true
• 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
• 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
• Phone: +437251222400
• Email: support@gtec.at
• Phone: +437251222400
• Email: support@gtec.at

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBCI80600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191432

FDA Product Code

• OLU: Normalizing Quantitative Electroencephalograph Software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-16
• Device Publish Date: 2020-03-06

Devices Manufactured by g.tec medical engineering GmbH

• EBCI5700PRO0 - g.Nautilus PRO: 2021-04-26 The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
• EBCI5710PRO0 - g.Nautilus PRO: 2021-04-26 The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
• EBCI5720PRO0 - g.Nautilus PRO: 2021-04-26 The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
• EBCI11700 - g.Estim FES: 2020-12-09 The g.Estim FES is a programmable constant-current stimulator that can deliver electrical pulses with alternating polarities, le
• EBCI7091US0 - g.HIamp: 2020-04-07 The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the
• EBCI7092US0 - g.HIamp: 2020-04-07 The g.HIamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the
• EBCI80600 - cortiQ PRO: 2020-03-16cortiQ PRO is a system that uses g.HIamp to map high-gamma broad band brain activity while running an experimental paradigm. The software helps to identify electrode positions coding differences in brain activity by means of experimental paradigm. cortiQ PRO performs the signal analysis in real-time and compares the high-gamma broad band activity during specific tasks. Then it performs a statistical analysis and visualizes electrodes coding the information that are statistically significant. It is abstracted from technical details of data acquisition, channel order and signal processing assuring robust and efficient measurements.
• EBCI80600 - cortiQ PRO: 2020-03-16 cortiQ PRO is a system that uses g.HIamp to map high-gamma broad band brain activity while running an experimental paradigm. The
• EBCI02160 - g.USBamp: 2020-02-21 The g.USBamp is inteded to measuring, recording and analysis of electrical activity of the brain (EEG) and/or through the attach