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Spacelabs Medical, Inc.
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SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 is an FDA 510(k)-cleared medical device (K060900) 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 June 22, 2006. Regulation: 8.