12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)
FDA 510(k) clearance K231026 · decided 2023-08-18
Clearance details
- K-number
- K231026
- Device name
- 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)
- Applicant
- Shenzhen Beacon Display Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-04-11
- Decision date
- 2023-08-18
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- PGY
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.