FORE-SIGHT ELITE Tissue Oximeter Module
510(k) K190270
FORE-SIGHT ELITE Tissue Oximeter Module is a Class II device made by Cas Medical Systems, Inc., cleared under FDA 510(k) K190270 on 21 Oct 2019, 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 | FDA 510(k)SESE | NumberK190270 | Date21 Oct 2019 | StatusActive |
Official records
- FDA 510(k) database K190270
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MUD
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2700
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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