Cleared Traditional

Delphi Amplifier

K243746 · Quantalx Neroscience · Neurology
Mar 2025
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K243746 is an FDA 510(k) clearance for the Delphi Amplifier, a Amplifier, Physiological Signal (Class II — Special Controls, product code GWL), submitted by Quantalx Neroscience (Kfar Sava, IL). The FDA issued a Cleared decision on March 12, 2025, 97 days after receiving the submission on December 5, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K243746 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2024
Decision Date March 12, 2025
Days to Decision 97 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWL — Amplifier, Physiological Signal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1835