DATEX-OHMEDA CS/3 TELEMETRY SYSTEM

DATEX-OHMEDA CS/3 TELEMETRY SYSTEM is an FDA 510(k)-cleared medical device (K000882) manufactured by Datex-Ohmeda. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 4, 2000. Regulation: 8.