AVIVA SYSTEMS MODEL NUMBERS 1010, 2020

AVIVA SYSTEMS MODEL NUMBERS 1010, 2020 is an FDA 510(k)-cleared medical device (K981533) manufactured by American Telecare, 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 July 14, 1998. Regulation: 8.