LIGHT-PEN SYSTEM FOR QUANTI. ANALY.

LIGHT-PEN SYSTEM FOR QUANTI. ANALY. is an FDA 510(k)-cleared medical device (K772158) manufactured by Varian Assoc., Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 21, 1977. Regulation: 8.