DeviceClearance

Product code GWQ— Neurology

Cadwell Apollo System

Classification name
Full-Montage Standard Electroencephalograph
Device class
Class 2
Regulation
21 CFR 882.1400
Advisory panel
Neurology
Total cleared
189
First cleared
Most recent

FDA classification definition

“Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations”

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

Market context for product code GWQ

FDA has cleared 189 devices under product code GWQ between 1977 and 2026, filed by 94 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

last 15 years

Top applicants under product code GWQ

Recent clearances under product code GWQ

1–100 of 189

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