PMB — External Airway Class II
FDA product code PMB covers "External Airway", a Class II medical device regulated under 21 CFR 868.5105. Submissions are reviewed by the Anesthesiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PMB
- Device Class
- Class II
- Regulation Number
- 868.5105
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
This device is intended to maintain airway patency using negative pressure during mild to moderate sedation.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN140024 | sommetrics | cNEP Airway | December 23, 2015 |