BcSs-PICNI-2000 Sensor— 510(k) K182073

Substantially Equivalent

Braincare Desenvolvimento E Inovacao Tecnologica S.A.

FDA 510(k) clearance K182073 for BcSs-PICNI-2000 Sensor, Substantially Equivalent on 2019-10-17. Applicant: Braincare Desenvolvimento E Inovacao Tecnologica S.A..

Clearance details

Applicant: Braincare Desenvolvimento E Inovacao Tecnologica S.A.
Product code: Code GWM
Advisory panel: Neurology
Date received: 2018-08-01
Decision date: 2019-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sao Carlos, BR

Download summary PDF View on FDA.gov ↗

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.