ENRAF-NONIUS SONOPULS 190 SYSTEM

ENRAF-NONIUS SONOPULS 190 SYSTEM is an FDA 510(k)-cleared medical device (K000084) manufactured by Henley Healthcare, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 3, 2000. Regulation: 8.