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FDA 510(k)

BcSs-PICNI-2000 Sensor

K-Number: K182073 · 2019-10-17

ApplicantBraincare Desenvolvimento E Inovacao Tecnologica S.A.
Decision Date2019-10-17
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BcSs-PICNI-2000 Sensor is a medical device manufactured by Braincare Desenvolvimento E Inovacao Tecnologica S.A.. It received FDA 510(k) clearance on 2019-10-17 under approval number K182073. 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 BcSs-PICNI-2000 Sensor?

BcSs-PICNI-2000 Sensor is a medical device that received FDA 510(k) clearance on 2019-10-17. It is manufactured by Braincare Desenvolvimento E Inovacao Tecnologica S.A.. The 510(k) number is K182073.

When was BcSs-PICNI-2000 Sensor approved by the FDA?

BcSs-PICNI-2000 Sensor received FDA 510(k) clearance on 2019-10-17, under approval number K182073.

What company makes BcSs-PICNI-2000 Sensor?

BcSs-PICNI-2000 Sensor is manufactured by Braincare Desenvolvimento E Inovacao Tecnologica S.A..

What is the FDA product code for BcSs-PICNI-2000 Sensor?

The FDA product code for BcSs-PICNI-2000 Sensor is GWM.

Other Devices by Braincare Desenvolvimento E Inovacao Tecnologica S.A.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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