HEARTRATE PLUS ECG CARDULE #1918

HEARTRATE PLUS ECG CARDULE #1918 is an FDA 510(k)-cleared medical device (K830306) 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 March 16, 1983. Regulation: 8.