DIGILAB MODULAR ONE-APPLANATION TONOMETER

DIGILAB MODULAR ONE-APPLANATION TONOMETER is an FDA 510(k)-cleared medical device (K863217) manufactured by Bio-Rad. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 23, 1986. Regulation: 8.