
Maquet Critical Care AB
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MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E is an FDA 510(k)-cleared medical device (K041223) 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 July 28, 2004. Regulation: 8.