K-number	K191432
Device name	cortiQ PRO
Applicant	G.Tec Medical Engineering GmbH
Product code	OLU
Device class	Class II
Decision date	Jan 24, 2020
Decision	Substantially Equivalent
Regulation	882.1400

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Source

View the full FDA submission: accessdata.fda.gov

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cortiQ PRO

Everything you need for a 510(k) submission. Nothing you don't.