510(k) DEN140024
- Device
- cNEP Airway
- Applicant
- Sommetrics
- 510(k) number
- DEN140024
- Product code
- PMB
- Decision
- Unknown (DENG)
- Decision date
- 2015-12-23
- Date received
- 2014-08-18
- Regulation
- 868.5105
- Classification name
- External Airway
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Richard Rose
- Address
- 16885 Via Del Campo, Suite 135 San Diego CA US 92127 92127
Source Documents
510(k) summary PDF not indicated by FDA
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00851167007001 | aerFree Airway Management System (AMS) | Sommetrics | 2017-09-11 |