MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160

MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160 is an FDA 510(k)-cleared medical device (K050399) manufactured by Invivo Research, 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 August 25, 2005. Regulation: 8.