Product code GXX— Neurology

RMI ULTRASOUND DOPPLER PHANTOM SYSTEM

Classification name
Block, Test, Ultrasonic Scanner Calibration
Device class
Class 1
Regulation
21 CFR 882.1925
Advisory panel
Neurology
Total cleared
3
First cleared
Most recent

Market context for product code GXX

FDA has cleared 3 devices under product code GXX between 1985 and 1989, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code GXX

Recent clearances under product code GXX

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