K252765
- 510(k) number
- K252765
- Device name
- ProSomnus RPMO2 OSA Device (RPMO2 OSA)
- Applicant
- Prosomnus Sleep Technologies CA · US
- Product code
- PLC — Sleep Appliances With Patient Monitoring
- Decision date
- 2026-04-06
- Date received
- 2025-08-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K252765.pdf
Official FDA record: K252765
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.