PULSE CARDULE (MODEL 1859/1860 ECG)

PULSE CARDULE (MODEL 1859/1860 ECG) is an FDA 510(k)-cleared medical device (K760120) manufactured by Spacelabs, 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 July 19, 1976. Regulation: 8.