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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 K172859
Device Name Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder
Applicant
Prosomnous Sleep Technologies
5860 W Las Positas Blvd.
Suite 25
Pleasanton,  CA  94588
Applicant Contact David Kuhns
Correspondent
Prosomnous Sleep Technologies
5860 W Las Positas Blvd.
Suite 25
Pleasanton,  CA  94588
Correspondent Contact David Kuhns
Regulation Number872.5570
Classification Product Code
PLC  
Subsequent Product Code
LRK  
Date Received09/20/2017
Decision Date 11/22/2017
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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