B4C System— 510(k) K201989

Name: FDA 510(k) clearance K201989
Creator: U.S. Food and Drug Administration
Published: 2021-10-08

Substantially Equivalent

Braincare Desenvolvimento E Inovacao Tecnologica S.A.

FDA 510(k) clearance K201989 for B4C System, Substantially Equivalent on 2021-10-08. Applicant: Braincare Desenvolvimento E Inovacao Tecnologica S.A.. Device class: 2.

Clearance details

Applicant: Braincare Desenvolvimento E Inovacao Tecnologica S.A.
Product code: Code GWM
Device class: Class 2
Regulation: 21 CFR 882.1620
Advisory panel: Neurology
Date received: 2020-07-17
Decision date: 2021-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: São Carlos, BR

Download summary PDF View on FDA.gov ↗

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K182073 — BcSs-PICNI-2000 Sensor2019-10-17

Adverse events under product code GWM

product code GWM

Death: 21
Injury: 732
Malfunction: 2,063
Other: 1
Total: 2,817

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.