K240821
- 510(k) number
- K240821
- Device name
- B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
- Applicant
- Braincare Desenvolvimento E Inovação Tecnológica S.A. BR
- Product code
- GWM — Device, Monitoring, Intracranial Pressure
- Decision date
- 2024-07-18
- Date received
- 2024-03-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240821.pdf
Official FDA record: K240821
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.