SPACELABS MEDICAL ECG ANALYSIS SYSTEM

SPACELABS MEDICAL ECG ANALYSIS SYSTEM is an FDA 510(k)-cleared medical device (K962930) 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 April 24, 1997. Regulation: 8.