Fore-Sight® 01-07-1004
Fore-Sight® 01-07-1004 is a Class II device made by Cas Medical Systems, Inc., cleared under FDA 510(k) K112820 on 26 Jan 2012 and listed in FDA GUDID since 6 Mar 2017 (UDI-DI 10609538710046), 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 | Number10609538710046 | Date6 Mar 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112820 | Date26 Jan 2012 | StatusActive |
Official records
- AccessGUDID record 10609538710046
- FDA 510(k) database K112820
Across registries
- FDA 510(k) K112820 decided 26 Jan 2012 Active
- FDA GUDID UDI-DI 10609538710046 listed 6 Mar 2017 Listed
Timeline
- Cleared FDA 510(k) K112820
- Listed FDA GUDID 10609538710046
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fore-Sight®
- Generic name
- Tissue saturation oximeter sensor, single-use
- Model / reference
- 01-07-1004
- Primary DI / UDI-DI
- 10609538710046
- 510(k) Number
- FDA product code
- MUD
- GMDN term
- Tissue saturation oximeter sensor, single-use
- Device class
- Class II
- Regulation number
- 870.2700
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 4.0 Centimeter
Similar devices in this category
Other devices filed under Tissue saturation oximeter sensor, single-use.