Product code PMB
- Device name
- External Airway
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5105
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- This device is intended to maintain airway patency using negative pressure during mild to moderate sedation.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| DEN140024 | cNEP Airway | Sommetrics | 2015-12-23 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00851167007001 | aerFree Airway Management System (AMS) | Sommetrics | 2017-09-11 |