AccessGUDID - DEVICE: cortiQ PRO (EBCI80600)

GUDID

Device Identifier (DI) Information

Brand Name: cortiQ PRO
Version or Model: TD 1.x
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: g.tec medical engineering GmbH

Primary DI Number: EBCI80600
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300916041 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35777	Electroencephalographic spectrum analyser	A mains electricity (AC-powered) electronic instrument used to display the frequency content or power spectral density of the electroencephalograph (EEG) signal. The device may also be referred to as a wave analyser.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OLU	Normalizing Quantitative Electroencephalograph Software
GWL	Amplifier, Physiological Signal
OLT	Non-Normalizing Quantitative Electroencephalograph Software

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191432	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 18d244af-e47c-4f55-88e6-9d4bd5e52aa2
Public Version Date: May 06, 2021
Public Version Number: 3
DI Record Publish Date: March 06, 2020