JASUN, MODELS DT-01F AND DT-11F

JASUN, MODELS DT-01F AND DT-11F is an FDA 510(k)-cleared medical device (K030361) manufactured by Hangzhou Hua'An Medical & Health Instruments Co.,. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 20, 2003. Regulation: 8.