K-number	K213645
Device name	ClearPoint Maestro Brain Model
Applicant	ClearPoint Neuro, Inc.
Product code	QIH
Device class	Class II
Decision date	Aug 8, 2022
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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ClearPoint Maestro Brain Model

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