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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K200657
Device Name SmartGuard Anti-Snoring Device
Applicant
Smartguard Rx, Inc.
2112 N. Hill Field Rd. Suite 2a
Layton,  UT  84041
Applicant Contact Brian Larsen
Correspondent
Smartguard Rx, Inc.
2112 N. Hill Field Rd. Suite 2a
Layton,  UT  84041
Correspondent Contact Brian Larsen
Regulation Number872.5570
Classification Product Code
LRK  
Date Received03/12/2020
Decision Date 08/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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