SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE

SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE is an FDA 510(k)-cleared medical device (K973596) manufactured by Spacelabs Medical, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 2, 1998. Regulation: 8.