MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL

MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL is an FDA 510(k)-cleared medical device (K901034) manufactured by Nihon Kohden America, 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 April 18, 1990. Regulation: 8.