SMARTWIRE/SMARTMAP PRESSURE SYSTEM

SMARTWIRE/SMARTMAP PRESSURE SYSTEM is an FDA 510(k)-cleared medical device (K021219) manufactured by Jomed, 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 May 16, 2002. Regulation: 8.