Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
FDA 510(k) clearance K254048 · decided 2026-05-14
Clearance details
- K-number
- K254048
- Device name
- Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
- Applicant
- Shenzhen Urion Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-12-17
- Decision date
- 2026-05-14
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- 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.