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Prosomnous Sleep Technologies
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Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder is an FDA 510(k)-cleared medical device (K172859) manufactured by Prosomnous Sleep Technologies. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 21, 2017. Regulation: 8.