BAXTER BIOSTAT 1000 UREA MONITOR

BAXTER BIOSTAT 1000 UREA MONITOR is an FDA 510(k)-cleared medical device (K925581) 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 May 2, 1995. Regulation: 8.