510(k) DEN140024
DEN140024 is an FDA 510(k) premarket notification submitted by Sommetrics for the device "cNEP Airway". The FDA issued a decision of De Novo Granted on December 23, 2015. The device falls under product code PMB (External Airway), a Class II device regulated under 21 CFR 868.5105.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 23, 2015
- Date Received
- August 18, 2014
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- External Airway
- Device Class
- Class II
- Regulation Number
- 868.5105
- Review Panel
- AN
- Submission Type
This device is intended to maintain airway patency using negative pressure during mild to moderate sedation.