K-number	K201989
Device name	B4C System
Applicant	Braincare Desenvolvimento E Inovacao Tecnologica S.A.
Product code	GWM
Device class	Class II
Decision date	Oct 8, 2021
Decision	Substantially Equivalent
Regulation	882.1620

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View the full FDA submission: accessdata.fda.gov

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B4C System

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