QBE

Cranial Sound Monitor

Product code

QBE

Device name

Cranial Sound Monitor

Device class

Class 2

21 CFR

21 CFR 870.1875

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

To non-invasively detect, monitor, record and display acoustic signals in the brain.

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