NeurotriS (SX2500); NeurotriS (SX3800)— 510(k) K251909

Substantially Equivalent

A-1 Engineering

FDA 510(k) clearance K251909 for NeurotriS (SX2500); NeurotriS (SX3800), Substantially Equivalent on 2025-09-03. Applicant: A-1 Engineering. Device class: 2.

Clearance details

Applicant
A-1 Engineering
Product code
Code NFO
Device class
Class 2
Regulation
21 CFR 882.5890
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
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