B4C System— 510(k) K201989
Substantially EquivalentBraincare 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..
Clearance details
- Applicant
- Braincare Desenvolvimento E Inovacao Tecnologica S.A.
- Product code
- Code GWM
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- São Carlos, BR
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, through . 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.