SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM

SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM is an FDA 510(k)-cleared medical device (K852608) manufactured by Ge Medical Systems Information Technologies. 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 September 26, 1985. Regulation: 8.