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510(k) Data Aggregation

    K Number
    K094003
    Device Name
    REVIVATOR
    Manufacturer
    Date Cleared
    2010-09-17

    (263 days)

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

    HERSILL, S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Revivator resuscitator is intended for pulmonary resuscitation. The adult resuscitator is for people with a body weight of more than 30 kg (66 lbs) The child resuscitator is for children with a body weight between 7 and 30 kg (15-66 lbs) The infant resuscitator is for infants with a body weight up to 7 kg (15 lbs)
    Device Description
    A resuscitator is a device using positive pressure to inflate the lungs of an unconscious person who is not breathing, in order to keep him oxygenated and alive. The manual resuscitators basically consist of a mask and a large hand-squeezed plastic bulb using ambient air, or supplemental oxygen. The air and oxygen flows into the resuscitator bag. And compressing the bag, the patient is ventilated. In order not to apply a high pressure to the patient's airways, the resuscitators include a pressure-limiting valve.
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    K Number
    K093241
    Device Name
    V7 PORTABLE SUCTION UNITS
    Manufacturer
    Date Cleared
    2010-04-27

    (194 days)

    Product Code
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    HERSILL, S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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