DeviceClearance

Product code GXW— Neurology

5.0 IOP & 7.5 IOP PROBES

Classification name
Echoencephalograph
Device class
Class 2
Regulation
21 CFR 882.1240
Advisory panel
Neurology
Total cleared
7
First cleared
Most recent

Market context for product code GXW

FDA has cleared 7 devices under product code GXW between 1977 and 1992, filed by 6 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

Top applicants under product code GXW

Recent clearances under product code GXW

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