Falck Medical Multifunction Tonometer, FAT1

Falck Medical Multifunction Tonometer, FAT1 is an FDA 510(k)-cleared medical device (K151491) manufactured by Falck Medical, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 14, 2016. Regulation: 8.