GENESIS HEALTH RECORD SYSTEM, (GHRS)

GENESIS HEALTH RECORD SYSTEM, (GHRS) is an FDA 510(k)-cleared medical device (K123136) manufactured by Genesis Health Technologies. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 6, 2013. Regulation: 8.