Product code QBE

Device name

Cranial Sound Monitor

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.1875

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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

Source

FDA openFDA device classification dataset