Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027532607

FEI Number

3027532607

Entity Name

ALLIANCE NEURODIAGNOSTICS, LLC, D/B/A STRATUS

City/State/Country

Irving, TX, US

Establishment Address

4545 Fuller Dr Ste 100, Irving, TX 75038, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Alliance Neurodiagnostics, LLC, d/b/a Stratus (Owner Number: 10091660)

Owner / Operator Contact Address

4545 Fuller Dr., Suite 100, Irving, TX 75038, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243788

PMA Number

N/A

All Registered Proprietary Names

IceCap 2 IceCap 2 Neonate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2024-10-22
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2024-10-22
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2025-04-22

Official Correspondent

Jennifer Armstrong

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Alliance Neurodiagnostics, LLC, d/b/a Stratus

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027532607. Last updated year: 2026. Please use registration number 3027532607 when referencing this establishment in official correspondence.