VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM— 510(k) K131434

Substantially Equivalent

Visionsense, Ltd.

FDA 510(k) clearance K131434 for VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM, Substantially Equivalent on 2013-07-16. Applicant: Visionsense, Ltd..

Clearance details

Applicant: Visionsense, Ltd.
Product code: Code GWG
Advisory panel: Neurology
Date received: 2013-05-17
Decision date: 2013-07-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

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.