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Nellcor Puritan Bennett, Inc.
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ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E is an FDA 510(k)-cleared medical device (K002686) manufactured by Nellcor Puritan Bennett, 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 October 17, 2000. Regulation: 8.