SPACELABS MEDICAL ECG MODULE (MODEL 90492)

SPACELABS MEDICAL ECG MODULE (MODEL 90492) is an FDA 510(k)-cleared medical device (K942058) 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 May 16, 1995. Regulation: 8.