Provent Nasal Dilator, Model BR2

FDA 510(k) K071560 · Ventus Medical, Inc.

Substantially Equivalent

510(k) numberK071560

Submission

Device name
Provent Nasal Dilator, Model BR2
Applicant
Ventus Medical, Inc.
Hillsborough, CA, US
Received
June 7, 2007
Decision date
February 8, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OHP – Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5570
Specialty
Dental

Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.

Other 510(k)s with product code OHP

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K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceOHP · Traditional Bryggs Medical, LLC02/21/2020SE
K180619BongoOHP · Traditional Innomed Healthscience, Inc.08/16/2018SE
K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…OHP · Traditional Ventus Medical, Inc.12/02/2010SE
K090398Provent Professional Sleep Apnea TherapyOHP · Traditional Ventus Medical, Inc.04/03/2009SE

More from Ventus Medical, Inc.

510(k)DeviceDecision
K120665Invent Snoring DeviceLWF · Traditional 06/12/2012SE
K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…OHP · Traditional 12/02/2010SE
K090398Provent Professional Sleep Apnea TherapyOHP · Traditional 04/03/2009SE
K080983Provent Nasal CannulaMNR · Traditional 08/07/2008SE

Questions and answers

When was Provent Nasal Dilator, Model BR2 cleared by the FDA?

Provent Nasal Dilator, Model BR2 (K071560) received a 510(k) decision of Substantially Equivalent on February 8, 2008, 246 days after the submission was received.

What is the product code of K071560?

The FDA product code is OHP – Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea, a Class II (moderate risk) device regulated under 21 CFR 872.5570.