BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM

BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM is an FDA 510(k)-cleared medical device (K965008) manufactured by Spacelabs Medical, 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 December 15, 1997. Regulation: 8.