K-number	K191701
Device name	Arcus Head Fixation Frame
Applicant	Mri Interventions, Inc.
Product code	HBL
Device class	Class II
Decision date	Nov 15, 2019
Decision	Substantially Equivalent
Regulation	882.4460

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Source

View the full FDA submission: accessdata.fda.gov

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Arcus Head Fixation Frame

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