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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 K252765
Device Name ProSomnus RPMO2 OSA Device (RPMO2 OSA)
Applicant
Prosomnus Sleep Technologies
5675 Gibraltar Dr.
Pleasanton,  CA  94588
Applicant Contact Divya Mavalli
Correspondent
Prosomnus Sleep Technologies
5675 Gibraltar Dr.
Pleasanton,  CA  94588
Correspondent Contact Divya Mavalli
Regulation Number872.5570
Classification Product Code
PLC  
Subsequent Product Codes
DQA   LQZ   LRK   OUG  
Date Received08/29/2025
Decision Date 04/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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