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510(k) Data Aggregation

    K Number
    K120665
    Device Name
    INVENT SNORING DEVICE
    Manufacturer
    VENTUS MEDICAL, INC.
    Date Cleared
    2012-06-12

    (99 days)

    Product Code
    LWF
    Regulation Number
    874.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    VENTUS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InVent Snoring Device is intended to reduce or eliminate snoring.
    Device Description
    As with the predicate device, the subject device is a nasal dilator intended to reduce or eliminate snoring. While the predicate device is an internal nasal dilator, the subject device is an external nasal dilator in which the device is placed over the patient's nostrils. As with the predicate device, the subject device creates dilating pressure or expiratory positive airway pressure (EPAP) to dilate and open the nasal airway. The device directs expiratory flow though selected pathways, which maintain nasal airway pressure and help maintain nasal passage dilation.
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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?
    Applicant Name (Manufacturer) :

    VENTUS MEDICAL, INC.

    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?
    Applicant Name (Manufacturer) :

    VENTUS MEDICAL, INC.

    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
    K080983
    Device Name
    PROVENT NASAL CANNULA
    Manufacturer
    VENTUS MEDICAL, INC.
    Date Cleared
    2008-08-07

    (122 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    VENTUS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Provent Nasal Cannula is indicated for the transmission of respiratory airflow signals between the Provent™ Professional Sleep Apnea Therapy device and the pressure transducers used with physiologic recorders during sleep studies.
    Device Description
    The Provent Nasal Cannula was developed to transmit pressure signals from the Provent Professional Sleep Apnea Therapy device to a pressure transducer of a physiologic recorder during sleep evaluations. The Provent Nasal Cannula is specifically designed to attach the Provent Professional Sleep Apnea Therapy (Provent PSAT, K071560) device to standard pressure transducers. The Provent Nasal Cannula is essentially identical to standard nasal cannulae except for its custom connection to the Provent PSAT. The Provent Nasal Cannula is comprised of the same design elements as a standard nasal cannula: 1. a bifurcated tube with a luer lock connector, 2. an anti-microbial filter at one end, and 3. a component to hold the tubes in the correct location near the nostrils at the other end. The Provent nasal cannula is worn in the same way as the standard nasal cannulae, with the proximal ends held in place in the path of nasal airflow and the tubing routed over the ears and under the chin.
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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?
    Applicant Name (Manufacturer) :

    VENTUS MEDICAL, INC.

    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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