MODIFICATION OF APEXPRO TELEMETRY SYSTEM

MODIFICATION OF APEXPRO TELEMETRY SYSTEM is an FDA 510(k)-cleared medical device (K021325) manufactured by General Electric Medical Systems Information Techn. 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 6, 2002. Regulation: 8.