BAXTER ACCURA SYSTEM, MODEL 5M5660

BAXTER ACCURA SYSTEM, MODEL 5M5660 is an FDA 510(k)-cleared medical device (K021615) manufactured by Baxter Healthcare Corp. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 17, 2002. Regulation: 8.