VivaSight-DL System
510(k) K181886
VivaSight-DL System is a Class II device made by Etview, Ltd., cleared under FDA 510(k) K181886 on 14 Nov 2018, 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 | NumberK181886 | Date14 Nov 2018 | StatusActive |
Official records
- FDA 510(k) database K181886
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CBI
- FDA applicant
- Etview , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5740
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
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