
Phasein AB
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EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG) is an FDA 510(k)-cleared medical device (K063167) manufactured by Phasein AB. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 5, 2007. Regulation: 8.