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510(k) K252765

ProSomnus RPMO2 OSA Device (RPMO2 OSA) by Prosomnus Sleep Technologies — Product Code PLC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2026
Date Received
August 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleep Appliances With Patient Monitoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy.

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