SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500

SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 is an FDA 510(k)-cleared medical device (K983572) manufactured by Healthdyne Technologies, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 18, 1999. Regulation: 8.