
Salter Labs
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BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER is an FDA 510(k)-cleared medical device (K051313) manufactured by Salter Labs. 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 14, 2005. Regulation: 8.