BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CDI OneView Monitoring System

    K Number: K234065 · Decision Apr 25, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    46
    Applicant Total
    29
    Review Days
    125

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    Basic Information

    Device Name
    CDI OneView Monitoring System
    K Number
    K234065
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo Cardiovascular Systems Corporation
    Date Received
    December 22, 2023
    Decision Date
    April 25, 2024
    Product Code
    DRY
    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
    DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

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