QEM

Cerebral Oximeter

Product code

QEM

Device name

Cerebral Oximeter

Device class

Class 2

21 CFR

21 CFR 870.2700

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

Oximeter to measure cerebral tissue saturation

Definition text from the FDA device classification database (U.S. federal government work, public domain).