K252360
- 510(k) number
- K252360
- Device name
- ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
- Applicant
- Anumana, Inc. MA · US
- Product code
- SAT — Pulmonary Hypertension Machine Learning-Based Notifi
- Decision date
- 2026-03-28
- Date received
- 2025-07-29
- 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: K252360.pdf
Official FDA record: K252360
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.