10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE

10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE is an FDA 510(k)-cleared medical device (K922573) manufactured by Boston Scientific Corp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 7, 1992. Regulation: 8.