K233666

CorVista System with PH Add-On

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.