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cortiQ PRO

FDA UDI

Class II (US FDA UDI)

by g.tec medical engineering GmbH

Identity

Trade Name
cortiQ PRO FDA UDI
Generic Name
Electroencephalographic spectrum analyser FDA UDI
Device Name
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. FDA UDI
Model / Reference
TD 1.x FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
EBCI80600 FDA UDI
510(k) Number
K191432 FDA UDI
FDA Product Code
OLU FDA UDI
GWL FDA UDI
OLT FDA UDI
GMDN Term
Electroencephalographic spectrum analyser FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1400 FDA UDI
882.1835 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electroencephalographic spectrum analyser

cortiQ PRO by g.tec medical engineering GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
g.tec medical engineering GmbH

Sources (1)

  • FDA UDI 18d244af-e47c-4f55-88e6-9d4bd5e52aa2 35 fields · synced Jun 8, 2026