QEM · Class II · 21 CFR 870.2700

FDA Product Code QEM: Cerebral Oximeter

Oximeter To Measure Cerebral Tissue Saturation

Leading manufacturers include Mespere Lifesciences, Inc..

1
Total
1
Cleared
128d
Avg days
2018
Since

FDA 510(k) Cleared Cerebral Oximeter Devices (Product Code QEM)

1 devices
1–1 of 1
Cleared Dec 26, 2018
VO200 – NeurOs Cerebral Oximetry System
K182242
Mespere Lifesciences, Inc.
General & Plastic Surgery · 128d

About Product Code QEM - Regulatory Context