Product code OLY

Device name

Magnetoencephalograph

Medical specialty

Neurology

Device class

2

Regulation number

882.1400

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

Acquire, display, store, and archive biomagnetic signals produced by electrically active nerve tissue in the brain to provide information about the location of active nerve tissue responsible for certain brain functions relative to brain anatomy.

Source

FDA openFDA device classification dataset