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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 a medical device manufactured by Braincare Desenvolvimento E Inovação Tecnológica S.A.. It received FDA 510(k) clearance on 2024-07-18 under approval 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. It is manufactured by Braincare Desenvolvimento E Inovação Tecnológica S.A.. The 510(k) number is K240821.

When was B4C System - Addition of new sensor model (BcSs-PICNIW-2000) approved by the FDA?

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

What company makes B4C System - Addition of new sensor model (BcSs-PICNIW-2000)?

B4C System - Addition of new sensor model (BcSs-PICNIW-2000) is manufactured by Braincare Desenvolvimento E Inovação Tecnológica S.A..

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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Related PubMed Literature

PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40006408 Improving Fall Classification Accuracy of Multi-Input Models Using Three-Axis Accelerometer and Heart Rate Variability Data. Sensors (Basel, Switzerland) (2025) PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

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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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