QMS MAPPING SYSTEM,MODEL 2000

QMS MAPPING SYSTEM,MODEL 2000 is an FDA 510(k)-cleared medical device (K990058) manufactured by Cathdata, 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 December 14, 1999. Regulation: 8.