21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)
FDA 510(k) clearance K233336 · decided 2024-05-21
Clearance details
- K-number
- K233336
- Device name
- 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)
- Applicant
- Acula Technology Corp.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-29
- Decision date
- 2024-05-21
- Days to decision
- 235 days
- Clearance type
- Traditional
- Product code
- PGY
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Taoyuan, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.