DeviceClearance

Product code GWL— Neurology

8-CH Electroencephalography Amplifier

Classification name
Amplifier, Physiological Signal
Device class
Class 2
Regulation
21 CFR 882.1835
Advisory panel
Neurology
Total cleared
53
First cleared
Most recent

Market context for product code GWL

FDA has cleared 53 devices under product code GWL between 1977 and 2025, filed by 38 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 GWL

Recent clearances under product code GWL

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