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510(k) Data Aggregation

    K Number
    K191728
    Device Name
    ULTepap Expiratory Positive Airway Pressure (EPAP) Device
    Manufacturer
    Bryggs Medical, LLC
    Date Cleared
    2020-02-21

    (239 days)

    Product Code
    OHP
    Regulation Number
    872.5570
    Why did this record match?
    Product Code :

    OHP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ULTepap ™ is indicated for use in the treatment of mild to moderate Obstructive Sleep Apnea (OSA) in adults> 66bs.
    Device Description
    The ULTepap™ is a single patient, reusable device intended to treat mild to moderate OSA. It is comprised of a soft silicon rubber body that contains a pair of bi-resistance airflow cartridges, has flanges to attach headgear, and has nasal pillows to interface with the nares. The device is held in place on the patients face by means of a common CPAP mask headgear which is provided in the packaging. The device creates a therapeutic level of positive pressure on exhalation by means of the airflow cartridges that allow air to enter the patient's upper airway without resistance on inhalation and created resistance to airflow on exhalation. The airflow cartridges are comprised of a cylinder and a flexible thin-walled shell which are aligned with the nasal pillows to allow unimpeded inspiration and partially restricted expiration to create the appropriate level of therapeutic back pressure. The thin-walled shells collapse on inspiration and re-inflate on expiration and create a restricted area for expiration by inflating and sealing the inner diameter of the cylinder, forcing expiration through a series of channels molded in the cylinder.
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    K Number
    K180619
    Device Name
    Bongo
    Manufacturer
    InnoMed Healthscience, Inc.
    Date Cleared
    2018-08-16

    (160 days)

    Product Code
    OHP
    Regulation Number
    872.5570
    Why did this record match?
    Product Code :

    OHP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bongo is indicated for use in the treatment of mild to moderate obstructive sleep apnea (OSA) in adults >66 lbs.
    Device Description
    The Bongo intranasal appliance is a simple device which is placed just inside the nostrils. The device directs expiratory flow through small vent ports which increases intranasal pressure similar to the expiratory portion of the breathing cycle during use of the predicate device. The Bongo consists of valve assemblies coupled with nasal inserts. The Bongo has soft nasal inserts to form a seal within the nasal openings. The nasal inserts are offered in various sizes.
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    K Number
    K102404
    Device Name
    PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)
    Manufacturer
    VENTUS MEDICAL, INC.
    Date Cleared
    2010-12-02

    (100 days)

    Product Code
    OHP
    Regulation Number
    872.5570
    Why did this record match?
    Product Code :

    OHP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PROVENT® Sleep Apnea Therapy Device is indicated for use in the treatment of obstructive sleep apnea (OSA).
    Device Description
    The PROVENT device is placed just inside the nostrils. The device directs expiratory flow through selected pathways, which increases intranasal pressure similar to the expiratory portion of the breathing cycle during CPAP use.
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    K Number
    K090398
    Device Name
    PROVENT PROFESSIONAL SLEEP APNEA THERAPY
    Manufacturer
    VENTUS MEDICAL, INC.
    Date Cleared
    2009-04-03

    (45 days)

    Product Code
    OHP
    Regulation Number
    872.5570
    Why did this record match?
    Product Code :

    OHP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PROVENT Professional Sleep Apnea Therapy Device - PROVENT 50 intended use is for the treatment of obstructive sleep apnea (OSA).
    Device Description
    The PROVENT device is placed just inside the nostrils. The device directs expiratory flow through selected pathways, which increases intranasal pressure similar to the expiratory portion of the breathing cycle during CPAP use.
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    K Number
    K071560
    Device Name
    PROVENT NASAL DILATOR, MODEL BR2
    Manufacturer
    VENTUS MEDICAL, INC.
    Date Cleared
    2008-02-08

    (246 days)

    Product Code
    OHP
    Regulation Number
    872.5570
    Why did this record match?
    Product Code :

    OHP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Provent™ Professional Sleep Apnea Therapy device is indicated for use in the treatment of obstructive sleep apnea (OSA).
    Device Description
    The Provent device is placed just inside the nostrils. The device directs expiratory flow through selected pathways, which increases intranasal pressure similar to the expiratory portion of the breathing cycle during CPAP use.
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