OHP — Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea Class II
Classification Details
- Product Code
- OHP
- Device Class
- Class II
- Regulation Number
- 872.5570
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Definition
Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K191728 | bryggs medical | ULTepap Expiratory Positive Airway Pressure (EPAP) Device | February 21, 2020 |
| K180619 | innomed healthscience | Bongo | August 16, 2018 |
| K102404 | ventus medical | PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEE | December 2, 2010 |
| K090398 | ventus medical | PROVENT PROFESSIONAL SLEEP APNEA THERAPY | April 3, 2009 |
| K071560 | ventus medical | PROVENT NASAL DILATOR, MODEL BR2 | February 8, 2008 |