
Spacelabs Medical, Inc.
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MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 is an FDA 510(k)-cleared medical device (K062095) 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 September 28, 2006. Regulation: 8.