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FDA 510(k)

B4C System - Addition of new sensor model (BcSs-PICNIW-2000)

K-Number: K240821 · 2024-07-18

ApplicantBraincare Desenvolvimento E Inovação Tecnológica S.A.
Decision Date2024-07-18
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

B4C System - Addition of new sensor model (BcSs-PICNIW-2000) is the device name listed in this FDA 510(k) record. The listed applicant is Braincare Desenvolvimento E Inovação Tecnológica S.A.. It received FDA 510(k) clearance on 2024-07-18 under 510(k) number K240821. 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 - Addition of new sensor model (BcSs-PICNIW-2000)?

B4C System - Addition of new sensor model (BcSs-PICNIW-2000) is a medical device that received FDA 510(k) clearance on 2024-07-18. The listed applicant is Braincare Desenvolvimento E Inovação Tecnológica S.A.. The 510(k) number is K240821.

When did B4C System - Addition of new sensor model (BcSs-PICNIW-2000) receive FDA 510(k) clearance?

B4C System - Addition of new sensor model (BcSs-PICNIW-2000) received FDA 510(k) clearance on 2024-07-18, under 510(k) number K240821.

Who is the listed applicant for B4C System - Addition of new sensor model (BcSs-PICNIW-2000)?

The FDA 510(k) record lists Braincare Desenvolvimento E Inovação Tecnológica S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B4C System - Addition of new sensor model (BcSs-PICNIW-2000)?

The FDA product code for B4C System - Addition of new sensor model (BcSs-PICNIW-2000) is GWM.

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Official Source

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