
Phasein AB
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ISA CO2, ISA AX+, ISA OR+ is an FDA 510(k)-cleared medical device (K103604) 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 April 5, 2011. Regulation: 8.