MODIFICATION TO: APEXPRO TELEMETRY SYSTEM

MODIFICATION TO: APEXPRO TELEMETRY SYSTEM is an FDA 510(k)-cleared medical device (K032369) manufactured by Ge Medical Systems Information Technologies. 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 14, 2003. Regulation: 8.