DeviceClearance

Product code GZO— Neurology

SUDOSCAN

Classification name
Device, Galvanic Skin Response Measurement
Device class
Class 2
Regulation
21 CFR 882.1540
Advisory panel
Neurology
Total cleared
26
First cleared
Most recent

Market context for product code GZO

FDA has cleared 26 devices under product code GZO between 1984 and 2015, filed by 19 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 GZO

Recent clearances under product code GZO

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