QBE · Class II · 21 CFR 870.1875

FDA Product Code QBE: Cranial Sound Monitor

To Non-invasively Detect, Monitor, Record And Display Acoustic Signals In The Brain.

Leading manufacturers include Headsense Medical, Inc..

1
Total
1
Cleared
167d
Avg days
2018
Since

FDA 510(k) Cleared Cranial Sound Monitor Devices (Product Code QBE)

1 devices
1–1 of 1
Cleared Mar 08, 2018
Neuro Assessment System NAS-1000
K172892
Headsense Medical, Inc.
Neurology · 167d

About Product Code QBE - Regulatory Context