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Cma Microdialysis AB
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MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K071984) manufactured by Cma Microdialysis AB. 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 26, 2008. Regulation: 8.