4K UHD LCD Monitor OEV321UH
FDA 510(k) clearance K220069 · decided 2022-03-09
Clearance details
- K-number
- K220069
- Device name
- 4K UHD LCD Monitor OEV321UH
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2022-01-10
- Decision date
- 2022-03-09
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hachioji-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display recall (Z-2761-2026) | Olympus Corporation of the Americas | 2026-07-20 |