CARDIACINDEX COMPUTER MODEL SP 1435

CARDIACINDEX COMPUTER MODEL SP 1435 is an FDA 510(k)-cleared medical device (K802476) manufactured by Gould, 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 November 18, 1980. Regulation: 8.