BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    Model 9160 VitaloQUB

    K Number: K223818 · Decision May 25, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    10
    Applicant Total
    5
    Review Days
    155

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    Basic Information

    Device Name
    Model 9160 VitaloQUB
    K Number
    K223818
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1760
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vitalograph Ireland, Ltd.
    Date Received
    December 21, 2022
    Decision Date
    May 25, 2023
    Product Code
    JEH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JEH Plethysmograph, Volume

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