All Purpose Cuff 98-0080-28
All Purpose Cuff 98-0080-28 is a Class II device made by SunTech Medical, Inc, cleared under FDA 510(k) K051904 on 9 Sep 2005 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 10840935101383), active as of 23 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 | Number10840935101383 | Date12 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK051904 | Date9 Sep 2005 | StatusActive |
Official records
- AccessGUDID record 10840935101383
- FDA 510(k) database K051904
Across registries
- FDA 510(k) K051904 decided 9 Sep 2005 Active
- FDA GUDID UDI-DI 10840935101383 listed 12 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K051904
- Listed FDA GUDID 10840935101383
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- All Purpose Cuff
- Generic name
- Blood pressure cuff, reusable
- Model / reference
- 98-0080-28
- Primary DI / UDI-DI
- 10840935101383
- 510(k) Number
- FDA product code
- DXQ
- GMDN term
- Blood pressure cuff, reusable
- Device class
- Class II
- Regulation number
- 870.1120
- GUDID distribution status
- In Commercial Distribution
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