SONOLAYER S, SSH-60A/SDS-60A

SONOLAYER S, SSH-60A/SDS-60A is an FDA 510(k)-cleared medical device (K853115) manufactured by Toshiba Medical Systems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 11, 1986. Regulation: 8.