DeviceClearance

Product code OHP— Dental

Bongo

Classification name
Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Device class
Class 2
Regulation
21 CFR 872.5570
Advisory panel
Dental
Total cleared
5
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code OHP under 21 CFR 872.5570, via openFDA

Market context for product code OHP

FDA has cleared 5 devices under product code OHP between 2008 and 2020, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OHP

Recent clearances under product code OHP

Data sourced from openFDA. This site is unofficial and independent of the FDA.