HUMI-FLOW, MODEL 6-850-00/ 01/02

HUMI-FLOW, MODEL 6-850-00/ 01/02 is an FDA 510(k)-cleared medical device (K010053) manufactured by Northgate Technologies, 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 October 22, 2001. Regulation: 8.