ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING

ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING is an FDA 510(k)-cleared medical device (K895763) manufactured by Healthdyne Cardiovascular, 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 21, 1989. Regulation: 8.