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510(k) Data Aggregation

    K Number
    K021981
    Device Name
    IVENT 201 PORTABLE VENTILATOR
    Manufacturer
    VERSAMED LTD.
    Date Cleared
    2003-08-13

    (422 days)

    Product Code
    NOU, CBK, DQA
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERSAMED LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require the following general modes of ventilatory support, as prescribed by an attending physician: - Assist/Control (Pressure Controlled or Volume Controlled) ● - SIMV (Pressure Controlled or Volume Controlled) . - CPAP/PSV ● The iVent™ 201 ventilator with Non-Invasive Portable Oximeter is suitable for intrahospital use, home and alternate-site use, transport and energy use. The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate. The iVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical speqification, limits.
    Device Description
    The Non-invasive Pulse Oximeter board, MS-5, connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via a serial digital interface. The iVent201 provides DC power and isolates the board from the mains power and ground.
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    K Number
    K011957
    Device Name
    IVENT 201 PORTABLE VENTILATOR
    Manufacturer
    VERSAMED LTD.
    Date Cleared
    2001-07-18

    (26 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERSAMED LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require the following general modes of ventilatory support, as prescribed by an attending physician: - . Assist/Control (Pressure Controlled or Volume Controlled) - SIMV (Pressure Controlled or Volume Controlled) ● - CPAP/PSV The iVent™ 201 ventilator is suitable for intra-hospital use, home and alternate-site use, transport and energy use. The iVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.
    Device Description
    The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is designed to treat a variety of clinical conditions. It can deliver oxygen-enriched air and may be used to administer nebulized medications by inhalation. The iVent™ 201 can use external AC or DC power supply and contains an internal battery. Its operation is controlled by the iVent™ 201 Software.
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    K Number
    K981668
    Device Name
    SMARTVENT 201 PORTABLE VENTILATOR
    Manufacturer
    VERSAMED LTD.
    Date Cleared
    1999-04-07

    (331 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERSAMED LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require the following general modes of ventilatory support, as prescribed by an attending physician: - Assist/Control (Pressure Controlled or Volume Controlled) . - SIMV (Pressure Controlled or Volume Controlled) . - CPAP/PSV The SmartVent™ 201 ventilator is suitable for intra-hospital use, home and alternate-site use, transport and energy use. The SmartVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.
    Device Description
    The SmartVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is designed to treat a variety of clinical conditions. It can deliver oxygen-enriched air and may be used to administer nebulized medications by inhalation. The SmartVent™ 201 can use external AC or DC power supply and contains an internal battery. Its operation is controlled by the SmartVent™ 201 Software.
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