cortiQ PRO
FDA 510(k) K191432 · G.Tec Medical Engineering GmbH
510(k) numberK191432
Submission
- Device name
- cortiQ PRO
- Applicant
- G.Tec Medical Engineering GmbH
Schiedlberg, AT - Received
- May 29, 2019
- Decision date
- January 24, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLU – Normalizing Quantitative Electroencephalograph Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.
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|---|---|---|---|
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| K202588 | BNA PlatformOLU · Traditional | Elminda, Ltd. | 12/07/2020SE |
| K171414 | qEEG-ProOLU · Traditional | Brainmaster Technologies, Inc. | 07/01/2018SE |
| K121119 | Bna Analysis SystemOLU · Traditional | Eiminda , Ltd. | 07/25/2014SE |
| K112077 | Hbidb - Human Brian Index SoftwareOLU · Traditional | Corscience GmbH & Co. KG | 03/09/2012SE |
| K050192 | BRC Software ProductOLU · Traditional | Brc Operations Pty Limited | 10/20/2005SE |
| K041263 | Neuroguide Analysis SystemOLU · Traditional | Applied Neuroscience, Inc. | 08/03/2004SE |
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Questions and answers
When was cortiQ PRO cleared by the FDA?
cortiQ PRO (K191432) received a 510(k) decision of Substantially Equivalent on January 24, 2020, 240 days after the submission was received.
What is the product code of K191432?
The FDA product code is OLU – Normalizing Quantitative Electroencephalograph Software, a Class II (moderate risk) device regulated under 21 CFR 882.1400.