FUKUDA SANGYO MODEL SPIROANALYZER ST-180

FUKUDA SANGYO MODEL SPIROANALYZER ST-180 is an FDA 510(k)-cleared medical device (K943546) manufactured by Spirosoft Northamerica, 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 February 22, 1995. Regulation: 8.