KOWA HAND-HELD APPLANATION TONOMETER HA-1

KOWA HAND-HELD APPLANATION TONOMETER HA-1 is an FDA 510(k)-cleared medical device (K960924) manufactured by Kowa Optimed, 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 3, 1996. Regulation: 8.