OHP · Class II · 21 CFR 872.5570

FDA Product Code OHP: Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

Intranasal Device That Creates Expiratory Resistance For The Treatment Of Obstructive Sleep Apnea.

Leading manufacturers include Ventus Medical, Inc., Innomed Healthscience, Inc. and Bryggs Medical, LLC.

5
Total
5
Cleared
158d
Avg days
2008
Since

FDA 510(k) Cleared Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea Devices (Product Code OHP)

5 devices
1–5 of 5
Cleared Feb 21, 2020
ULTepap Expiratory Positive Airway Pressure (EPAP) Device
K191728
Bryggs Medical, LLC
Anesthesiology · 239d
Cleared Aug 16, 2018
Bongo
K180619
Innomed Healthscience, Inc.
Ear, Nose, Throat · 160d
Cleared Dec 02, 2010
PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80)
K102404
Ventus Medical, Inc.
Dental · 100d
Cleared Apr 03, 2009
PROVENT PROFESSIONAL SLEEP APNEA THERAPY
K090398
Ventus Medical, Inc.
Dental · 45d
Cleared Feb 08, 2008
PROVENT NASAL DILATOR, MODEL BR2
K071560
Ventus Medical, Inc.
Dental · 246d

About Product Code OHP - Regulatory Context