SARNS 7000 MONITOR MODULE

SARNS 7000 MONITOR MODULE is an FDA 510(k)-cleared medical device (K801097) manufactured by 3M Health Care, Sarns. 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 19, 1980. Regulation: 8.