Product code QEM

Device name
Cerebral Oximeter
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.2700
Review panel
NE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
Oximeter to measure cerebral tissue saturation
Source
FDA openFDA device classification dataset