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Pulmonetic Systems, Inc.
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MODIFICATION TO LTV 1000 VENTILATOR is an FDA 510(k)-cleared medical device (K040540) manufactured by Pulmonetic Systems, 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 April 28, 2004. Regulation: 8.