K-number	K213930
Device name	Brainlab Elements Guide XT, Guide 3.0
Applicant	Brainlab AG
Product code	QQC
Device class	Class II
Decision date	Apr 19, 2022
Decision	Substantially Equivalent
Regulation	882.5855

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Source

View the full FDA submission: accessdata.fda.gov

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Brainlab Elements Guide XT, Guide 3.0

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