ViSi Cuff Module
ViSi Cuff Module (92-10011) is a Class II device made by Sotera Wireless, cleared under FDA 510(k) K152341 on 14 Dec 2015 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00850733007018), 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 | Number00850733007018 | Date19 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152341 | Date14 Dec 2015 | StatusActive |
Official records
- AccessGUDID record 00850733007018
- FDA 510(k) database K152341
Across registries
- FDA 510(k) K152341 decided 14 Dec 2015 Active
- FDA GUDID UDI-DI 00850733007018 listed 19 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K152341
- Listed FDA GUDID 00850733007018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ViSi
- Generic name
- General-purpose multi-parameter bedside monitor
- Model / Ref / Catalog
- Cuff Module, 92-10011
- Primary DI / UDI-DI
- 00850733007018
- 510(k) Number
- FDA product code
- DXN
- GMDN term
- General-purpose multi-parameter bedside monitor
- Device class
- Class II
- Regulation number
- 870.1130
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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