SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800)

SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800) is an FDA 510(k)-cleared medical device (K003701) manufactured by Sentech Medical Systems, 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 April 4, 2001. Regulation: 8.