
Falck Medical, Inc.
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FALCK APPLANATION TONOMETER (FAT2) is an FDA 510(k)-cleared medical device (K071755) 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 June 2, 2008. Regulation: 8.