510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SFNClass II

Non-Invasive Evoked Response Brain Stimulator

21 CFR 882.1860 / Neurology
FDA source (opens on fda.gov)

SFN is the FDA product code for Non-Invasive Evoked Response Brain Stimulator, a class II device type, regulated under 21 CFR 882.1860. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SFN
Device name
Non-Invasive Evoked Response Brain Stimulator
FDA 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.
Regulation
21 CFR 882.1860
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SFN

By decision year
1 clearance under product code SFN with a decision year between 2025 and 2025, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SFN by decision year
YearClearances
20251

Applicants with the most clearances

Product code SFN
Applicants holding the most 510(k) clearances under product code SFN
ApplicantClearances
Quantalx Neuroscience1

Companies listing this code with FDA

Companies whose registered establishments list this code