ViSi
ViSi (97-10259) 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 24 Jun 2020 (UDI-DI 00850733007414), active as of 21 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 | Number00850733007414 | Date24 Jun 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152341 | Date14 Dec 2015 | StatusActive |
Official records
- AccessGUDID record 00850733007414
- FDA 510(k) database K152341
Across registries
- FDA 510(k) K152341 decided 14 Dec 2015 Active
- FDA GUDID UDI-DI 00850733007414 listed 24 Jun 2020 Listed
Timeline
- Cleared FDA 510(k) K152341
- Listed FDA GUDID 00850733007414
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- General-purpose multi-parameter bedside monitor
- Model / Ref / Catalog
- ViSi Emergency Medical Surveillance (EMS) Kit, 97-10259
- Primary DI / UDI-DI
- 00850733007414
- 510(k) Number
- FDA product code
- DXN, MWI, DSI, MHX
- GMDN term
- General-purpose multi-parameter bedside monitor
- Device class
- Class II
- Regulation number
- 870.1130, 870.2300, 870.1025
- GUDID distribution status
- In Commercial Distribution
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