ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.

ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. is an FDA 510(k)-cleared medical device (K901084) 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 May 31, 1990. Regulation: 8.