SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION

SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION is an FDA 510(k)-cleared medical device (K962970) manufactured by Spacelabs Medical, 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 24, 1997. Regulation: 8.