Abox U80H
by Shenzhen Urion Technology Co., Ltd
Abox U80H is a Class II device made by Shenzhen Urion Technology Co., Ltd, cleared under FDA 510(k) K160019 on 22 Apr 2016 and listed in FDA GUDID since 15 Jun 2018 (UDI-DI 06953825903411), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06953825903411 | Date15 Jun 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160019 | Date22 Apr 2016 | StatusActive |
Official records
- AccessGUDID record 06953825903411
- FDA 510(k) database K160019
Across registries
- FDA 510(k) K160019 decided 22 Apr 2016 Active
- FDA GUDID UDI-DI 06953825903411 listed 15 Jun 2018 Listed
Timeline
- Cleared FDA 510(k) K160019
- Listed FDA GUDID 06953825903411
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Abox
- Generic name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
- Model / reference
- U80H
- Primary DI / UDI-DI
- 06953825903411
- 510(k) Number
- FDA product code
- DXN
- GMDN term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
- Device class
- Class II
- Regulation number
- 870.1130
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Automatic-inflation electronic sphygmomanometer, portable, arm/wrist.