VIVASIGHT-DL SYSTEM— 510(k) K123853

Substantially Equivalent

Etview , Ltd.

FDA 510(k) clearance K123853 for VIVASIGHT-DL SYSTEM, Substantially Equivalent on 2013-04-15. Applicant: Etview , Ltd..

Clearance details

Applicant: Etview , Ltd.
Product code: Code CBI
Advisory panel: Anesthesiology
Date received: 2012-12-14
Decision date: 2013-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Binyamina, IL

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Adverse events under product code CBI

product code CBI

Death: 4
Malfunction: 594
Total: 598

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.