BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)

    K Number: K222822 · Decision Jun 14, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    8
    Review Days
    268

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    Basic Information

    Device Name
    VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
    K Number
    K222822
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5270
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Draegerwerk AG & CO Kgaa
    Date Received
    September 19, 2022
    Decision Date
    June 14, 2023
    Product Code
    BZE
    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
    BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

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    Other Clearances by Draegerwerk AG & CO Kgaa

    K Number Device Name
    K253647 Evita (V800); Evita (V600)
    K242769 VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)
    K222024 Evita V800, Evita V600
    K222207 Babylog VN800, Babylog VN600
    K221118 CO2 Mainstream Sensor
    K162821 Babyleo TN500
    K093633 INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE