MAC-LAB ELECTROPHYSIOLOGY MODULE OPTION

MAC-LAB ELECTROPHYSIOLOGY MODULE OPTION is an FDA 510(k)-cleared medical device (K935394) manufactured by Marquette Electronics, 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 October 19, 1994. Regulation: 8.