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510(k) Data Aggregation

    K Number
    K051279
    Device Name
    CALDYNE, INC. EXHALOMETER EX100, MODEL EX100
    Manufacturer
    CALDYNE, INC.
    Date Cleared
    2005-09-07

    (113 days)

    Product Code
    BZK, CAH
    Regulation Number
    868.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    CALDYNE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EXHALOMETER™ EX100 is intended to measure the tidal volume, minute volume and respiration rate being delivered to the patient via expiratory ports of resuscitation devices such as transport ventilators and resuscitators. The device is primarily used by Emergency Medical Technicians during emergency transport operations and can also be used for intra-hospital transport. The device is used for indicating how well the resuscitator is functioning. In addition, the device is used for periodically checking the adequacy of the ventilation effort of patients who have initiated spontaneous respiration. The EXHALOMETER can also be used for training and developing resuscitation techniques.
    Device Description
    The EXHALOMETER™ EX100 is a device that is a self contained and internally powered analyzer designed to connect to a specially designed filter assembly, which in turn, connects to the expiratory port of resuscitation devices such as transport ventilators and resuscitators. The device measures exhaled air from the patient and provides data that indicates the tidal volume, minute volume, and respiration rate being delivered to the patient. The patient does not inhale through the device. This device is primarily used by Emergency Medical Technicians and has been designed to be rugged enough to reliably operate in environments encountered in emergency transport operation, including a wide range of temperatures, shock and vibration and electro-magnetic fields. The device and its parts have been designed with adequate mechanical strength so that when subjected to mechanical stress caused by normal use such as pushing, impact, dropping, and rough handling, the will device function normally and will present no potential safety hazard to the patient.
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