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510(k) Data Aggregation

    K Number
    K221841
    Device Name
    EOlife®
    Manufacturer
    ARCHEON
    Date Cleared
    2023-03-18

    (267 days)

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

    ARCHEON

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EOlife is intended for use with emergency manual resuscitation devices to measure ventilatory flows and display visual guide on the insufflated volume, and ventilation frequency to ensure adequate ventilation of adult cardiopulmonary arrest patient during cardiopulmonary resuscitation (CPR) performed by healthcare professionals.
    Device Description
    EOlife is a medical device dedicated to healthcare professionals to help them providing manual ventilation during cardiopulmonary resuscitation (CPR). EOlife is intended to be connected to any standard manual resuscitator for adults including a bag and a mask or endotracheal tube (ET tube) and supraglottic airway (SGA) device and to be used during manual ventilation of an adult cardiopulmonary arrest patient. EOlife is a portable device composed of an electronic control unit including an embedded software, a removable and rechargeable battery pack and of a single use flow sensor: FlowSense. EOlife does not present direct contact with the patient. Only the ventilation air flow is in contact with the internal part of FlowSense (indirect contact with the patient). During manual ventilation, EOlife measures the ventilation parameters (insufflated volumes, tidal volumes, ventilation frequencies, ) and gives real-time feedback to the user about the quality of the ventilation provided to the patient compared to the 2020 AHA (American Heart Association) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, Part 3: Adult Basic and Advanced Life Support. The aim is to help the user ventilate according to the recommended frequencies (10 cycles per minute) and volumes (6-8 ml/kg of ideal body weight).
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