K252204
- 510(k) number
- K252204
- Device name
- prolaio eVO2peak Module (Version 1.0)
- Applicant
- Prolaio, Inc. IL · US
- Product code
- PPW — Adjunctive Cardiovascular Status Indicator
- Decision date
- 2025-12-16
- Date received
- 2025-07-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K252204.pdf
Official FDA record: K252204
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.