510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191432Substantially Equivalent

cortiQ PRO

G.tec Medical Engineering GmbH, Schiedlberg, AT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191432 is the FDA 510(k) clearance record for cortiQ PRO, a class II device, cleared for G.Tec Medical Engineering GmbH on under FDA product code OLU (Normalizing Quantitative Electroencephalograph Software). FDA's definition for product code OLU reads: "Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user". FDA records list 6 510(k) clearances for G.Tec Medical Engineering GmbH, from to . As of , FDA records show no recalls naming K191432.

Clearance record

Decision date
Received
(240 days to decision)
Product code
OLU Normalizing Quantitative Electroencephalograph Software
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
G.Tec Medical Engineering GmbH Sierningerstrasse 14, Schiedlberg, AT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLU

Trailing 12 months
1 clearance under product code OLU in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OLU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260