BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    CorVista System with PH Add-On

    K Number: K233666 · Decision Apr 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    142

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CorVista System with PH Add-On
    K Number
    K233666
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2380
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Analytics For Life, Inc.
    Date Received
    November 15, 2023
    Decision Date
    April 5, 2024
    Product Code
    SAT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SAT Pulmonary Hypertension Machine Learning-Based Notification Software

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (SAT), ordered by most recent decision date.

    ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all