K-number	K223615
Device name	Digital ClarusScope System, Digital NeuroPEN System
Applicant	Clarus Medical, LLC
Product code	GWG
Device class	Class II
Decision date	Nov 21, 2023
Decision	Substantially Equivalent
Regulation	882.1480

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View the full FDA submission: accessdata.fda.gov

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Digital ClarusScope System, Digital NeuroPEN System

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