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Salter Labs, Division of Regulatory Affairs
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SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR is an FDA 510(k)-cleared medical device (K080922) manufactured by Salter Labs, Division of Regulatory Affairs. 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 24, 2008. Regulation: 8.