510(k) K071560
K071560 is an FDA 510(k) premarket notification submitted by Ventus Medical, Inc. for the device "PROVENT NASAL DILATOR, MODEL BR2". The FDA issued a decision of Substantially Equivalent on February 8, 2008. The device falls under product code OHP (Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea), a Class II device regulated under 21 CFR 872.5570. Ventus Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2008
- Date Received
- June 7, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type
Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.