DeviceClearance

Product code GWE— Neurology

ACCUMAP AUTOMATIC PERIMETER

Classification name
Stimulator, Photic, Evoked Response
Device class
Class 2
Regulation
21 CFR 882.1890
Advisory panel
Neurology
Total cleared
49
First cleared
Most recent

Market context for product code GWE

FDA has cleared 49 devices under product code GWE between 1978 and 2022, filed by 37 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 GWE

Recent clearances under product code GWE

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