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Respironics California, Inc.
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ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000 is an FDA 510(k)-cleared medical device (K051262) manufactured by Respironics California, 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 July 7, 2005. Regulation: 8.