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510(k) Data Aggregation

    K Number
    K141595
    Device Name
    O-TWO E700,O-TWO E600,O-TWO E500
    Manufacturer
    O-TWO MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2015-03-16

    (276 days)

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

    O-TWO MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    o two e700, e600 and e500 are a time-cycled, volume-constant and pressure-controlled (only e700) emergency and transport ventilator designed for use in the pre-hospital, inter-hospital and transport settings. It is intended for use with adult, child, infant patients with a tidal volume from 50 ml (100 ml for e500) upwards who are in respiratory and/or cardiac arrest or respiratory distress and who require ventilatory support.
    Device Description
    The proposed o_two e700, o_two e600 and o_two e500 are time-cycled, volume-constant and pressure controlled (o_two e700 only) emergency and transport ventilators. They are electronically controlled, pneumatically powered ventilators which can be run using AC/DC power adapter or an internal rechargeable Lithium Ion battery pack. The devices use a 4.3" TFT screen to display live ventilation parameters (Tidal and minute volumes, proximal airway pressure and breathing rate) as well as ventilation pressure & volume wave forms, ventilation modes, settings, alarm limits and battery status. The wide range of both visual and audible alarms provides the healthcare professional with warnings of any changes in patient or device parameters.
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    K Number
    K113687
    Device Name
    EQUINOX RELIEVE
    Manufacturer
    O-TWO MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2012-04-30

    (137 days)

    Product Code
    BZR, BTL
    Regulation Number
    868.5330
    Why did this record match?
    Applicant Name (Manufacturer) :

    O-TWO MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is indicated for delivering a 50%/ 50% mixture of nitrous oxide and oxygen, on demand, to a conscious, spontaneously breathing patient.
    Device Description
    The proposed Equinox Relieve® Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device designed to provide a 50/50% nitrous oxide and oxygen mixture. The device provides two input connection with nitrous oxide and oxygen cylinders through pressure regulators. The device has only one control for turning ON or OFF the device. When it is turned ON, the output of N20/02 gas mixture will only be activated by an inspiratory effort by the patient. The out put of N20/O2 gas mixture is pre-set at 50/50%. Neither the patient nor medical personnel are able to adjust, eliminating the risk of delivering a hypoxic mixture. The gas specific built-in alarm system will generate both visual and audible alarms should either nitrous oxide or oxygen input fall below 40 PSI, and the device will automatically shut off should either nitrous oxide or oxygen input fall below 35 PSL. The device is also equipped with a secondary "fail safe" circuit that will activate an alarm and shut off the device should internal malfunction occur in the mixer or any internal hoses rupture or kink. The main accessories for the proposed device are a disposable Patient Circuit and a universal Face Mask.
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    K Number
    K112546
    Device Name
    O_TWO CPAP SYSTEM
    Manufacturer
    O-TWO MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2011-12-27

    (117 days)

    Product Code
    BYE
    Regulation Number
    868.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    O-TWO MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    o two CPAP System is intended to provide a constant positive airway pressure to spontaneously breathing patients in the hospital environment and emergency medical service applications to treat patients in respiratory distress.
    Device Description
    The o two CPAP device provides a constant positive airway pressure to the lungs of patients in respiratory distress from Pulmonary Emphysema, Congestive Heart Failure and a number of other obstructive airway conditions. This open system has no moving parts and uses a "vectored flow valve" to create a wall of resistance to expiration and an additive flow to inspiration. By varying the oxygen flow through the valve the baseline pressure can be raised or lowered to maintain a positive airway pressure. The rise in baseline pressure keeps alveoli from collapsing, forces fluid in the lungs back intro the interstitium and improves medication delivery.
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    K Number
    K093862
    Device Name
    CAREVENT HANDHELD CPAP SYSTEM
    Manufacturer
    O-TWO MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2010-05-06

    (140 days)

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

    O-TWO MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAREvent Handheld CPAP System is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environments.
    Device Description
    The proposed CAREvent Handheld CPAP System is a pneumatically powered device designed to provide CPAP (Constant Positive Airway Pressure) to spontaneously breathing patients who require respiratory support. The patient can breathe spontaneously through the device while the device provides constant positive airway pressure via a face mask. It has only one control for the adjustment of CPAP pressure from 0 to 20 cmH2O. The device may be used in pre-hospital transport applications including accident scene, emergency rescue vehicles, hospital transport applications including emergency, surgery, post anesthesia/ recovery and air transport via helicopter or fixed wing. The device is a restricted medical device intended for use by qualified medical personnel under the direction of a physician. The main accessories for the proposed device are Patient Circuit, Face Mask and Airway Pressure Manometer. They are all disposable for single-patient use.
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    K Number
    K081330
    Device Name
    CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
    Manufacturer
    O-TWO MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2009-03-06

    (298 days)

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

    O-TWO MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAREvent PAR (Public Access Resuscitator) is indicated for Cardio Pulmonary Resuscitation (CPR) and short -term ventilatory support. It incorporates voice instructions, compression beeps and automatic ventilations to assist CPR Trained personnel for both inter - and intra-hospital transport and pre-hospital (EMS) settings for non-breathing adult patients.
    Device Description
    The CAREvent PAR® is an electronically controlled, pneumatically powered resuscitator with a . 12V, internal, rechargeable battery is used to power the electronics. It incorporababliator instructions to assist the user during CPR.
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    K Number
    K051469
    Device Name
    CAREVENT ATV+ AND CAREVENT MRI
    Manufacturer
    O-TWO MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2005-09-28

    (117 days)

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

    O-TWO MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAREvent ATV+ and CAREvent MRI are pneumatically powered, time cycled, intermittent, positive pressure automatic transport ventilator used to provide resuscitation and/or ventilatory support to a wide range of patients (from above 5 kg (11 lbs.) and higher) during transport. They are designed to be used by suitably trained medical personnel in the prehospital, Intra-hospital, inter-hospital and air ambulance settings. In addition CAREvent MRI is suitable for use in 1.5 - 3.0 Tesla MRI medical imaging suite environments, where ventilatory support may also be required during an MRI imaging procedure. The ventilator is suitable for use in: - · Pulmonary resuscitation during respiratory and/or cardiac arrest. - · Short term ventilatory support in the pre-hospital, Intra-hospital, inter-hospital and air ambulance transport of non-breathing patients. - · In addition CAREvent MRI only is suitable for use in 1.5 3.0 Tesla MRI medical imaging suite environments, where ventilatory support may also be required during an MRI imaging procedure.
    Device Description
    Not Found
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    K Number
    K051889
    Device Name
    CAREVENT CA AND DRA
    Manufacturer
    O-TWO MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2005-08-30

    (49 days)

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

    O-TWO MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAREvent CA and CAREvent DRA are pneumatically powered, time/volume cycled ventilators used to provide ventilatory support in confined space rescue in IDLH (Immediately Dangerous to Life and Health) environment. The ventilator is suitable for use in: Pulmonary resuscitation during respiratory and/or cardiac arrest. Short term ventilatory support in the confined space rescue in IDLH (Immediately Dangerous to Life and Health) environment, pre-hospital, Intra-hospital and inter-hospital transport of non-breathing patients.
    Device Description
    The CAREvent CA and CAREvent DRA are pneumatically powered, time/volume cycled ventilators.
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