AVIVA SYSTEM, MODEL SL1010

AVIVA SYSTEM, MODEL SL1010 is an FDA 510(k)-cleared medical device (K993550) 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 January 12, 2000. Regulation: 8.