ProSomnus RPMO2 OSA Device (RPMO2 OSA)— 510(k) K252765

Substantially Equivalent

Prosomnus Sleep Technologies

FDA 510(k) clearance K252765 for ProSomnus RPMO2 OSA Device (RPMO2 OSA), Substantially Equivalent on 2026-04-06. Applicant: Prosomnus Sleep Technologies.

Clearance details

Applicant
Prosomnus Sleep Technologies
Product code
Code PLC
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pleasanton, CA, US
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