K234065
- 510(k) number
- K234065
- Device name
- CDI OneView Monitoring System
- Applicant
- Terumo Cardiovascular Systems Corporation MI · US
- Product code
- DRY — Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Decision date
- 2024-04-25
- Date received
- 2023-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K234065.pdf
Official FDA record: K234065
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.