
Maquet Critical Care AB
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SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION is an FDA 510(k)-cleared medical device (K062793) 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 6, 2007. Regulation: 8.