Delphi Stimulator

FDA 510(k) K242345 · Quantalx Neuroscience

Substantially Equivalent

510(k) numberK242345

Submission

Device name
Delphi Stimulator
Applicant
Quantalx Neuroscience
Kfar Sava, IL
Received
August 7, 2024
Decision date
November 5, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWF – Stimulator, Electrical, Evoked Response
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1870
Specialty
Neurology

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K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)GWF · Traditional Soterix Medical, Inc.03/25/2024SE
K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressGWF · Special Inomed Medizintechnik GmbH10/27/2023SE
K230415Cadwell GuardianGWF · Traditional Cadwell Industries, Inc.08/17/2023SE
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Questions and answers

When was Delphi Stimulator cleared by the FDA?

Delphi Stimulator (K242345) received a 510(k) decision of Substantially Equivalent on November 5, 2024, 90 days after the submission was received.

What is the product code of K242345?

The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.