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

Name: FDA 510(k) clearance K131434
Creator: U.S. Food and Drug Administration
Published: 2013-07-16

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.. Device class: 2.

Clearance details

Applicant: Visionsense, Ltd.
Product code: Code GWG
Device class: Class 2
Regulation: 21 CFR 882.1480
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 ↗

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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.