BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1

BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1 is an FDA 510(k)-cleared medical device (K991831) manufactured by Boston Medical Technologies, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 10, 1999. Regulation: 8.