SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM

SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM is an FDA 510(k)-cleared medical device (K951605) manufactured by Spacelabs, 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 July 13, 1995. Regulation: 8.