FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3

FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3 is an FDA 510(k)-cleared medical device (K950420) manufactured by Analogic Corp.. 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 May 14, 1995. Regulation: 8.