510(k) K180619
K180619 is an FDA 510(k) premarket notification submitted by Innomed Healthscience, Inc. for the device "Bongo". The FDA issued a decision of Substantially Equivalent on August 16, 2018. 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2018
- Date Received
- March 9, 2018
- 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.