
Automedx, Inc.
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SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12 is an FDA 510(k)-cleared medical device (K071221) manufactured by Automedx, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 5, 2007. Regulation: 8.