SILENT GUARD CAT. NO. SG-30

SILENT GUARD CAT. NO. SG-30 is an FDA 510(k)-cleared medical device (K851465) manufactured by American Omni Medical, 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 August 4, 1985. Regulation: 8.