DeviceClearance

Product code SFN— Neurology

Delphi-MD System

Classification name
Non-Invasive Evoked Response Brain Stimulator
Device class
Class 2
Regulation
21 CFR 882.1860
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification definition

“A non-invasive evoked response brain stimulator is a non-penetrating device used to apply a stimulus to the brain for the purpose of measuring the evoked brain activity response.”

— U.S. Food and Drug Administration, device classification record for product code SFN under 21 CFR 882.1860, via openFDA

Market context for product code SFN

FDA has cleared 1 device under product code SFN, all in 2025, 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 SFN

Recent clearances under product code SFN

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