DeviceClearance

Product code OLY— Neurology

BABYMEG BIOMAGNETOMETER SYSTEM

Classification name
Magnetoencephalograph
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Total cleared
6
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OLY under 21 CFR 882.1400, via openFDA

Market context for product code OLY

FDA has cleared 6 devices under product code OLY between 1986 and 2020, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OLY

Recent clearances under product code OLY

Data sourced from openFDA. This site is unofficial and independent of the FDA.