
Datascope Corp.
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SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX is an FDA 510(k)-cleared medical device (K031849) manufactured by Datascope Corp.. 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 8, 2003. Regulation: 8.