PM-8000 PATIENT MONITOR, MODEL 8000

PM-8000 PATIENT MONITOR, MODEL 8000 is an FDA 510(k)-cleared medical device (K032733) manufactured by Shenzhen Mindray Bio-Medical Electronics 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 March 2, 2004. Regulation: 8.