K242518
- 510(k) number
- K242518
- Device name
- Hypertension Prediction Index (HePI) Algorithm
- Applicant
- Edwards Lifesciences, LLC CA · US
- Product code
- QAQ — Adjunctive Predictive Cardiovascular Indicator
- Decision date
- 2025-05-15
- Date received
- 2024-08-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242518.pdf
Official FDA record: K242518
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.