ONGUARD 1000, CATALOG #043611-000 & 043611-001

ONGUARD 1000, CATALOG #043611-000 & 043611-001 is an FDA 510(k)-cleared medical device (K870976) manufactured by Cobe Laboratories, 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 May 5, 1987. Regulation: 8.