K233666
- 510(k) number
- K233666
- Device name
- CorVista System with PH Add-On
- Applicant
- Analytics For Life, Inc. CA
- Product code
- SAT — Pulmonary Hypertension Machine Learning-Based Notifi
- Decision date
- 2024-04-05
- Date received
- 2023-11-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K233666.pdf
Official FDA record: K233666
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.