SoftCheck ST1826FL
SoftCheck ST1826FL is a Class II device made by Reprocessing Products Corp, cleared under FDA 510(k) K940214 on 22 Feb 1994 and listed in FDA GUDID since 30 Aug 2019 (UDI-DI 00858293006557), 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 | Number00858293006557 | Date30 Aug 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK940214 | Date22 Feb 1994 | StatusActive |
Official records
- AccessGUDID record 00858293006557
- FDA 510(k) database K940214
Across registries
- FDA 510(k) K940214 decided 22 Feb 1994 Active
- FDA GUDID UDI-DI 00858293006557 listed 30 Aug 2019 Listed
Timeline
- Cleared FDA 510(k) K940214
- Listed FDA GUDID 00858293006557
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SoftCheck
- Generic name
- Blood pressure cuff, single-use
- Model / reference
- ST1826FL
- Primary DI / UDI-DI
- 00858293006557
- 510(k) Number
- FDA product code
- DXQ
- GMDN term
- Blood pressure cuff, single-use
- Device class
- Class II
- Regulation number
- 870.1120
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code DXQ (Blood Pressure Cuff).
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- CLEEN-ABLE by Vital Signs, Inc.
- HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M- by Heine Optotechnik GmbH & Co. KG
- Blood Pressure Cuff (1201D1, 12L2D1, 1202D1, 12L3D1, 1203D1, 1204D1, 1205D1, 1206D1, 1207D1-1#, 1207D1-2#, 1207D1-3#, 1207D1-4#, 1207D1-5#, 1201B1, 12L2B1, 1202B1, 12L3B1, 1203B1, 1204B1, 1205B1, 1206B1, 1207B1-1#, 1207B1-2#,,1207B1-3#, 1207B1-4#, 1207B1-5#, 1201W2, 12L2W2, 1202W2, 12L3W2, 1203W2, 1204W2, 1205W2, 1206W2 and 1207W2) by Shenzhen Plinma Technology Co., Ltd