SIRECUST 341 AND 341R

SIRECUST 341 AND 341R is an FDA 510(k)-cleared medical device (K854881) manufactured by Siemens Medical Solutions USA, Inc.. 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 10, 1986. Regulation: 8.