OBIX PERINATAL DATA SYSTEM 7.0

OBIX PERINATAL DATA SYSTEM 7.0 is an FDA 510(k)-cleared medical device (K121208) manufactured by Clinical Computer Systems, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 13, 2012. Regulation: 8.