OptiScanner® 5000 Glucose Monitoring System

OptiScanner® 5000 Glucose Monitoring System is an FDA 510(k)-cleared medical device (K192785) manufactured by Optiscan Biomedical Corporation. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 4, 2020. Regulation: 8.