DEVICE: cortiQ PRO (EBCI80600)

Device Identifier (DI) Information

cortiQ PRO
TD 1.x
In Commercial Distribution

g.tec medical engineering GmbH
EBCI80600
HIBCC

1
300916041 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

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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.
Obsolete false
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FDA Product Code

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

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

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

18d244af-e47c-4f55-88e6-9d4bd5e52aa2
May 06, 2021
3
March 06, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Customer Contact

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+437251222400
support@gtec.at
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