K252241
- 510(k) number
- K252241
- Device name
- Pressio 3 Multi-parameter Neuromonitoring System
- Applicant
- Sophysa FR
- Product code
- GWM — Device, Monitoring, Intracranial Pressure
- Decision date
- 2026-04-10
- Date received
- 2025-07-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252241.pdf
Official FDA record: K252241
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.