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Found 5 results
510(k) Data Aggregation
K Number
K191728Device Name
ULTepap Expiratory Positive Airway Pressure (EPAP) Device
Manufacturer
Bryggs Medical, LLC
Date Cleared
2020-02-21
(239 days)
Product Code
OHP
Regulation Number
872.5570Why 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
K180619Device Name
Bongo
Manufacturer
InnoMed Healthscience, Inc.
Date Cleared
2018-08-16
(160 days)
Product Code
OHP
Regulation Number
872.5570Why 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
K102404Device 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
872.5570Why 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
K090398Device Name
PROVENT PROFESSIONAL SLEEP APNEA THERAPY
Manufacturer
VENTUS MEDICAL, INC.
Date Cleared
2009-04-03
(45 days)
Product Code
OHP
Regulation Number
872.5570Why 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
K071560Device Name
PROVENT NASAL DILATOR, MODEL BR2
Manufacturer
VENTUS MEDICAL, INC.
Date Cleared
2008-02-08
(246 days)
Product Code
OHP
Regulation Number
872.5570Why 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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