CDI OneView Monitoring System
FDA 510(k) clearance K234065 · decided 2024-04-25
Clearance details
- K-number
- K234065
- Device name
- CDI OneView Monitoring System
- Applicant
- Terumo Cardiovascular Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-12-22
- Decision date
- 2024-04-25
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- DRY
- Device class
- 2
- Regulation number
- 870.4330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - recall (Z-2018-2025) | Terumo Cardiovascular Systems Corporation | 2025-06-24 |
| Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number recall (Z-1492-2025) | Terumo Cardiovascular Systems Corporation | 2025-03-31 |