PMB · Class II · 21 CFR 868.5105

FDA Product Code PMB: External Airway

This Device Is Intended To Maintain Airway Patency Using Negative Pressure During Mild To Moderate Sedation.

Leading manufacturers include Sommetrics.

1
Total
0
Cleared
492d
Avg days
2015
Since

FDA 510(k) Cleared External Airway Devices (Product Code PMB)

1 devices
1–1 of 1
Not Cleared Dec 23, 2015
cNEP Airway
DEN140024
Sommetrics
Anesthesiology · 492d

About Product Code PMB - Regulatory Context