B4C System
K-Number: K201989 · 2021-10-08
Decision Date2021-10-08
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
B4C System is a medical device manufactured by Braincare Desenvolvimento E Inovacao Tecnologica S.A.. It received FDA 510(k) clearance on 2021-10-08 under approval number K201989. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the B4C System?
B4C System is a medical device that received FDA 510(k) clearance on 2021-10-08. It is manufactured by Braincare Desenvolvimento E Inovacao Tecnologica S.A.. The 510(k) number is K201989.
When was B4C System approved by the FDA?
B4C System received FDA 510(k) clearance on 2021-10-08, under approval number K201989.
What company makes B4C System?
B4C System is manufactured by Braincare Desenvolvimento E Inovacao Tecnologica S.A..
What is the FDA product code for B4C System?
The FDA product code for B4C System is GWM.
Other Devices by Braincare Desenvolvimento E Inovacao Tecnologica S.A.
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Official Source
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