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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleep Appliances With Patient Monitoring
510(k) Number K233497
Device Name Rest Assure System
Applicant
Somnomed, Inc.
6513 Windcrest Dr., Suite 100
Plano,  TX  75024
Applicant Contact Ty Cowart
Correspondent
Somnomed, Inc.
6513 Windcrest Dr., Suite 100
Plano,  TX  75024
Correspondent Contact Timothy Cowart
Regulation Number872.5570
Classification Product Code
PLC  
Subsequent Product Codes
LQZ   LRK  
Date Received10/31/2023
Decision Date 10/03/2024
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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