OLY · Class II · 21 CFR 882.1400

FDA Product Code OLY: Magnetoencephalograph

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.

Leading manufacturers include Compumedics Limited and Philips Medical Systems (Cleveland), Inc..

6
Total
6
Cleared
208d
Avg days
1986
Since

FDA 510(k) Cleared Magnetoencephalograph Devices (Product Code OLY)

6 devices
1–6 of 6
Cleared Feb 14, 2020
Orion LifeSpan MEG
K191785
Compumedics Limited
Neurology · 226d
Cleared Oct 31, 1996
NEUROMAG-122
K962764
Philips Medical Systems (Cleveland), Inc.
Neurology · 107d

About Product Code OLY - Regulatory Context