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510(k) Data Aggregation

    K Number
    K192177
    Device Name
    SysMed S/T
    Date Cleared
    2020-11-25

    (471 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    SysMed (China) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device provides positive pressure therapy for the treatment of adult obstructive sleep apnea syndrome in self breathing patients weighing over 30kg (66lbs). This product can be used in the home as well as in clinical/hospital environments.
    Device Description
    The proposed device is a non-invasive, continuous positive airway pressure ventilator, incorporating a heated respiratory humidifier. The device is intended to treat obstructive sleep apnea by delivering a flow of positive airway pressure at a level prescribed by a physician to splint open the airway and prevent airway collapse. The proposed device is available in three types, which are Aurora, Resware and Zizmer. Each type is available in different models designed with different therapy modes and pressure ranges. The therapy modes are available in four types, which are CPAP, Spontaneous (S), Spontaneous/Timed (S/T) and Timed (T). The pressure range for the proposed devices is available in three types, which are 4-20cm H2O, 4-25cm H2O and 4-30cm H2O. Alarm module is incorporated in the device. The device will generate audio and visual alarm for airway leakage, motor malfunction and high motor temperature. The proposed device is provided non-sterile, and not to be sterilized by the user prior to use. The proposed device can be reused by single patient.
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    K Number
    K172234
    Device Name
    Oxygen Concentrator
    Date Cleared
    2018-06-01

    (311 days)

    Product Code
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    SysMed (China) Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Oxygen Concentrator is intended for the administration of supplemental oxygen. This device is not intended for life supporting nor does it provide any patient monitoring capabilities. The system will be operated by trained personnel, at home, in community health care and medical institutions.
    Device Description
    The Oxygen Concentrator adopts the principle of pressure swing adsorption technology. At normal temperature, the device can continuously supply a high concentration of supplemental oxygen (93%±3%). The main function of the proposed device includes supplying supplemental oxygen. The device also includes alarms for high temperature, low oxygen output, and interruption of power. The proposed device includes three models, which are M50, M40 and M30. The only difference of the three models is flow rate.
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