VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)— 510(k) K082667

Substantially Equivalent

Visionsense, Ltd.

FDA 510(k) clearance K082667 for VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM), Substantially Equivalent on 2008-10-30. Applicant: Visionsense, Ltd..

Clearance details

Applicant: Visionsense, Ltd.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2008-09-12
Decision date: 2008-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

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.