Cleared Traditional

Delphi Stimulator

K242345 · Quantalx Neuroscience · Neurology

Nov 2024

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K242345 is an FDA 510(k) clearance for the Delphi Stimulator, a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Quantalx Neuroscience (Kfar Sava, IL). The FDA issued a Cleared decision on November 5, 2024, 90 days after receiving the submission on August 7, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number	K242345 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 07, 2024
Decision Date	November 05, 2024
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF