
Smartguard Rx, Inc.
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SmartGuard Anti-Snoring Device is an FDA 510(k)-cleared medical device (K200657) manufactured by Smartguard Rx, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 22, 2021. Regulation: 8.