510(k) K191432
K191432 is an FDA 510(k) premarket notification submitted by G.Tec Medical Engineering GmbH for the device "cortiQ PRO". The FDA issued a decision of Substantially Equivalent on January 24, 2020. The device falls under product code OLU (Normalizing Quantitative Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400. G.Tec Medical Engineering GmbH has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 2020
- Date Received
- May 29, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Normalizing Quantitative Electroencephalograph Software
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- NE
- Submission Type
Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.