Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020494684

FEI Number

3020494684

Entity Name

QUANTALX NEUROSCIENCE

City/State/Country

Kfar Saba Central, IL

Establishment Address

1 Hatachana st., Kfar Saba Central 4453001, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

QuantalX Neuroscience (Owner Number: 10094309)

Owner / Operator Contact Address

1 Hatachana st., Kfar Saba, IL-M 4453001, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243243

PMA Number

N/A

All Registered Proprietary Names

Delphi Stimulator Delphi-MD Delphi Software Delphi Probe Delphi MCS cap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SFN	Non-Invasive Evoked Response Brain Stimulator	Neurology	Class 2	882.1860	2025-11-23
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2025-11-23

Official Correspondent

Hilla Fogel

US Agent Details

Klaus Dahmen Business: QuantalX Neuroscience US Inc. Email: klaus@quantalx.com Phone: (262) 6176636

Related Public Records

Same Entity

QuantalX Neuroscience

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

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3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020494684. Last updated year: 2026. Please use registration number 3020494684 when referencing this establishment in official correspondence.