SCHILLER MODEL SP-200 SPIROVIT(TM)

SCHILLER MODEL SP-200 SPIROVIT(TM) is an FDA 510(k)-cleared medical device (K896121) manufactured by Schiller America, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 8, 1990. Regulation: 8.