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