MONITOR KITS, BLOOD LEVEL

MONITOR KITS, BLOOD LEVEL is an FDA 510(k)-cleared medical device (K781145) 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 July 26, 1978. Regulation: 8.