DEVICE: cortiQ PRO (EBCI80600)
Device Identifier (DI) Information
cortiQ PRO
TD 1.x
In Commercial Distribution
g.tec medical engineering GmbH
TD 1.x
In Commercial Distribution
g.tec medical engineering GmbH
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
Labeling does not contain MRI Safety Information | |
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No | |
No | |
Yes | |
No | |
No | |
Yes | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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OLU | Normalizing Quantitative Electroencephalograph Software |
GWL | Amplifier, Physiological Signal |
OLT | Non-Normalizing Quantitative Electroencephalograph Software |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K191432 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
18d244af-e47c-4f55-88e6-9d4bd5e52aa2
May 06, 2021
3
March 06, 2020
May 06, 2021
3
March 06, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+437251222400
support@gtec.at
support@gtec.at