MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE

MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE is an FDA 510(k)-cleared medical device (K861845) manufactured by Directed Energy, 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 August 10, 1986. Regulation: 8.