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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 K202529
Device Name ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring
Applicant
Prosomnus Sleep Technologies, Inc.
5860 W. Las Positas Blvd.
Pleasanton,  CA  94588
Applicant Contact Divya Mavalli
Correspondent
Prosomnus Sleep Technologies, Inc.
5860 W. Las Positas Blvd.
Pleasanton,  CA  94588
Correspondent Contact Divya Mavalli
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Codes
LQZ   PLC  
Date Received09/01/2020
Decision Date 11/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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