
American Telecare, Inc.
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AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010 is an FDA 510(k)-cleared medical device (K003999) 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 June 27, 2001. Regulation: 8.