FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER

FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER is an FDA 510(k)-cleared medical device (K970866) manufactured by Georgia Biomedical, 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 January 22, 1998. Regulation: 8.