BIONET BM3PLUS PATIENT MONITOR

BIONET BM3PLUS PATIENT MONITOR is an FDA 510(k)-cleared medical device (K082008) manufactured by Bionet Co., Ltd.. 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 10, 2008. Regulation: 8.