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510(k) Data Aggregation

    K Number
    K083418
    Device Name
    CPR MASK
    Date Cleared
    2010-07-22

    (611 days)

    Product Code
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIRSTAR HEALTHCARE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FS-104 CPR mask with oxygen port is indicated for use of mouth to mask ventilation via the ventilation mask with non-rebreathing valve for adult and child whose weight exceeds 40kg. It is for prescription use. The FS-104 CPR mask with oxygen port is intended for single use only.
    Device Description
    (1) The CPR mask with oxygen port is composed of foldable cushion mask with Oxygen Port, one- way valve, disposable filter, and elastic head trap. (2) The CPR mask with oxygen port provides a physical barrier between the rescuer and victim, eliminating direct contact of the rescuer's lips with unknown subject. (3) The CPR mask with oxygen port promotes an airtight seal to the face allowing ventilation through both the mouth and nose simultaneously. Proper training in ventilation and CPR should be obtained before using this device. (4) The CPR mask with oxygen port can be functioned in such a way that no any part of device extends into the patient's oral cavity by more than 2 cm. (5) For the device with capability of using oxygen is to sale as prescription device
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