AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR

AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR is an FDA 510(k)-cleared medical device (K981939) manufactured by Bci Intl., 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 August 19, 1998. Regulation: 8.