GENESIS DM MODEL: 6053000A1

GENESIS DM MODEL: 6053000A1 is an FDA 510(k)-cleared medical device (K101242) manufactured by Honeywell Hommed, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 10, 2010. Regulation: 8.