PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500

PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 is an FDA 510(k)-cleared medical device (K113183) manufactured by Shanghai 3f 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 February 8, 2012. Regulation: 8.