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510(k) Data Aggregation

    K Number
    K030864
    Device Name
    VADI MANUAL RESUSCITATOR
    Manufacturer
    VEDI CORP.
    Date Cleared
    2004-01-30

    (318 days)

    Product Code
    BTM
    Regulation Number
    868.5915
    Why did this record match?
    Applicant Name (Manufacturer) :

    VEDI CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VADI Manual Resuscitator is designed for use as an adjunct to artificial respiration and cardiopulmonary resuscitation. The Resuscitator can be used to ventilate the aphonic patient and to augment ventilation and/or oxygen delivery to the spontaneously breathing patient. The infant model is intended for patients weighing up to 10 kg, the child model is intended for patients weighing between 10 and 30 kg, and the adult model is intended for patients weighing more than 30 kg.
    Device Description
    Not Found
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