Huxley SANSA Home Sleep Apnea Test (1000-00)

Huxley SANSA Home Sleep Apnea Test (1000-00) is an FDA 510(k)-cleared medical device (K240285) manufactured by Huxley Medical. 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 14, 2024. Regulation: 8.