ABDOMINAL FETAL ECG MODULE

ABDOMINAL FETAL ECG MODULE is an FDA 510(k)-cleared medical device (K770245) manufactured by Mennen Greatbatch Electonics. 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 February 13, 1977. Regulation: 8.