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510(k) Data Aggregation

    K Number
    K991195
    Device Name
    CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV
    Manufacturer
    O-TWO SYSTEMS INTL., INC.
    Date Cleared
    1999-04-22

    (14 days)

    Product Code
    BTL
    Regulation Number
    868.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    O-TWO SYSTEMS INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Pulmonary resuscitation during respiratory and/or cardiac arrest. - Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.
    Device Description
    The CAREvent BLS automatic/manually triggered resuscitators are designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation and Manual Ventilation into a single handpiece design that is a derivative of the Genesis® II BLS device. The device is totally pneumatic in its function therefore requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi. The CAREvent ALS automatic/manually triggered resuscitators are designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation and Manual Ventilation into a single handpiece design that is a derivative of the Genesis® " Adult/Child device. The device is totally pneumatic in its function therefore requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi. The CAREvent BLS* is an automatic time cvcled resuscitator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic and Manual Ventilation into a control module with separate hose and patient valve. This device is identical in terms of features to the Autovent 1000 - 510K #: K983785 with the addition of the ability to select the manual flowrate equivalent to that selected on the tidal volume/frequency control. The device is a pneumatically powered, requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi. The device is a time-cycled ventilator with a range of 12, pre-set, automatic settings in which both the tidal volume and frequency of ventilation are adjusted simultaneously by the rotation of a vertically mounted rotary control. A manual button is provided to enable the operator to control the patient's breathing parameters with a flowrate equivalent to that selected on the tidal volume/frequency control. The patient's airway is protected by an over pressure alarm, pre-set to 60 cmHzO. which gives an audible signal of over pressure and vents the remaining tidal volume delivery for that breath to atmosphere. The CAREvent ATV is an automatic time cycled ventilator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation, Manual Ventilation, and Demand Breathing into a control module with separate hose and patient valve. This device is identical in terms of features to the Autovent 1500 product - 510K # K983857 with the addition of independent minute volume and frequency controls. adjustable pressure relief, 60/100% air/oxygen mix and the ability to select the manual flowrate with a flowrate equivalent to that selected on the minute volume control. An additional alarm feature has also been added to warn of low input pressure. The device is a pneumatically powered, requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi. The device is a time-cycled ventilator with a range of 12, automatic frequency settings and 12 minute volume settings which are both adjusted by the rotation of a vertically mounted rotary control. A manual button is provided to enable the operator to control the patient's breathing parameters with a flowrate equivalent to that selected on the minute volume control. Should the patient commence spontaneous breathing while being ventilated, their inspiratory effort will cause the device to provide breathing on demand while simultaneously causing the automatic cycling to cease. Should the patient cease to breathe spontaneously the automatic cycling will recommence without intervention by the operator being necessary. The patient's airway is protected by an over pressure alarm (adjustable from 20 to 60 cmH20), which gives an audible signal of over pressure and vents the remaining tidal volume delivery for that breath to atmosphere. The CAREvent ALS is an automatic time cycled resuscitator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation, Manual Ventilation, and Demand Breathing into a control module with separate hose and patient valve. This device is identical in terms of features to the Autovent 1500 product - 510K # K983857 with the addition of the ability to select the manual flowrate with a flowrate equivalent to that selected on the tidal volume/frequency control. The device is a pneumatically powered, requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi. The device is a time-cycled ventilator with a range of 12, pre-set automatic settings in which both the tidal volume and frequency of ventilation are adjusted simultaneously by the rotation of a vertically mounted rotary control. A manual button is provided to enable the operator to control the patient's breathing parameters with a flowrate equivalent to that selected on the tidal volume/frequency control. Should the patient commence spontaneous breathing while being ventilated, their inspiratory effort will cause the device to provide breathing on demand while simultaneously causing the automatic cycling to cease. Should the patient cease to breathe spontaneously the automatic cycling will recommence without intervention by the operator being necessary. The patient's airway is protected by an over pressure alarm, pre-set to 60 cmHzO. which gives an audible signal of over pressure and vents the remaining tidal volume delivery for that breath to atmosphere.
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    K Number
    K983857
    Device Name
    AUTOVENT 1500
    Manufacturer
    O-TWO SYSTEMS INTL., INC.
    Date Cleared
    1998-11-04

    (2 days)

    Product Code
    BTL
    Regulation Number
    868.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    O-TWO SYSTEMS INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pulmonary resuscitation during respiratory and/or cardiac arrest. Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.
    Device Description
    The Autovent 1500 is an automatic time cycled resuscitator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation, Manual Ventilation, and Demand Breathing into a control module with separate hose and patient valve. This device is identical in terms of features to the Flynn Genesis product - 510K # K913039/B except in the range of automatic settings of the device which have been extended and chosen to provide the output requirements of the latest AHA recommendations.
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    K Number
    K983643
    Device Name
    GENESIS BLS
    Manufacturer
    O-TWO SYSTEMS INTL., INC.
    Date Cleared
    1998-10-29

    (13 days)

    Product Code
    BTL
    Regulation Number
    868.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    O-TWO SYSTEMS INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Pulmonary resuscitation during respiratory and/or cardiac arrest. - Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.
    Device Description
    The Genesis® BLS automatic/manually triggered resuscitators are designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation and Manual Ventilation into a single handpiece design that is a derivative of the Genesis® " Adult/Child device. The device is totally pneumatic in its function therefore requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi.
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    K Number
    K983705
    Device Name
    EMT RESUSCITATOR
    Manufacturer
    O-TWO SYSTEMS INTL., INC.
    Date Cleared
    1998-10-29

    (8 days)

    Product Code
    BTL
    Regulation Number
    868.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    O-TWO SYSTEMS INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Pulmonary resuscitation during respiratory and/or cardiac arrest. - Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.
    Device Description
    The EMT automatic/manually triggered resuscitators are designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic Ventilation and Manual Ventilation into a single handpiece design that is a derivative of the Genesis® II Adult/Child device. The device is totally pneumatic in its function therefore requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi.
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    K Number
    K983785
    Device Name
    AUTOVENT 1000
    Manufacturer
    O-TWO SYSTEMS INTL., INC.
    Date Cleared
    1998-10-29

    (2 days)

    Product Code
    BTL
    Regulation Number
    868.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    O-TWO SYSTEMS INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Pulmonary resuscitation during respiratory and/or cardiac arrest. - Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.
    Device Description
    The Autovent 1000 is an automatic time cycled resuscitator designed to provide respiratory support to patients in either respiratory arrest or respiratory distress. The device incorporates the features of Automatic and Manual Ventilation into a control module with separate hose and patient valve. This device is identical in terms of features to the Genesis® II Adult/Child resuscitator -510K #: K932170. The range of automatic settings of the device have been extended and chosen to provide the output requirements of the latest AHA recommendations and in the removal of the demand breathing function. An automatic/manual on/off control has been added which is separate from the frequency/volume control as in the predicate device. The device is a pneumatically powered, requiring no batteries or other power sources apart from a compressed gas supply of either air or oxygen (as specified by the customer) and a regulated output from the gas source between 50 and 90 psi. The device is a time-cycled ventilator with a range of 12, pre-set, automatic settings in which both the tidal volume and frequency of ventilation are adjusted simultaneously by the rotation of a vertically mounted rotary control. A manual button is provided to enable the operator to control the patient's breathing parameters. The patient's airway is protected by an over pressure alarm, pre-set to 60 cmHzO, which gives an audible signal of over pressure and vents the remaining tidal volume delivery for that breath to atmosphere.
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    K Number
    K960995
    Device Name
    CPR BIO-BARRIER FACESHEILD
    Manufacturer
    O-TWO SYSTEMS INTL., INC.
    Date Cleared
    1997-01-07

    (301 days)

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

    O-TWO SYSTEMS INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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