BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    VENTRAIN

    K Number: K132759 · Decision Mar 26, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    99
    Applicant Total
    1
    Review Days
    203

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    Basic Information

    Device Name
    VENTRAIN
    K Number
    K132759
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5925
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dolphys Medical B.V.
    Date Received
    September 4, 2013
    Decision Date
    March 26, 2014
    Product Code
    BTL
    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
    BTL Ventilator, Emergency, Powered (Resuscitator)

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