K251367
- 510(k) number
- K251367
- Device name
- OptoMonitor 3
- Applicant
- Opsens, Inc. CA
- Product code
- DXO — Transducer, Pressure, Catheter Tip
- Decision date
- 2026-01-16
- Date received
- 2025-05-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K251367.pdf
Official FDA record: K251367
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.