DeviceClearance

Product code QEM— Cardiovascular

VO200 – NeurOs Cerebral Oximetry System

Classification name
Cerebral Oximeter
Device class
Class 2
Regulation
21 CFR 870.2700
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification definition

“Oximeter to measure cerebral tissue saturation”

— U.S. Food and Drug Administration, device classification record for product code QEM under 21 CFR 870.2700, via openFDA

Market context for product code QEM

FDA has cleared 1 device under product code QEM, all in 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QEM

Recent clearances under product code QEM

Data sourced from openFDA. This site is unofficial and independent of the FDA.