
Maquet Critical Care AB
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SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800 is an FDA 510(k)-cleared medical device (K063404) manufactured by Maquet Critical Care 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 14, 2007. Regulation: 8.