DeviceClearance

Product code NEQ— Gastroenterology, Urology

SOCRATES ROBOTIC TELEMONITORING SYSTEM

Classification name
Device, Telemedicine, Robotic
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

Market context for product code NEQ

FDA has cleared 2 devices under product code NEQ, all in 2001, filed by 1 applicant company. 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.

Top applicants under product code NEQ

Recent clearances under product code NEQ

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