MORGAN NEWTON COMPANY

FDA Device Registration & Listing · Plano, TX, US · Registration 3008312728

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008312728
FEI Number
3008312728
Entity Name
MORGAN NEWTON COMPANY
City/State/Country
Plano, TX, US
Establishment Address
3401 Wynwood Drive, Plano, TX 75074, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Morgan Newton Company (Owner Number: 10059741)
Owner / Operator Contact Address
3401 Wynwood Drive, Plano, TX 75074, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ObjectiveFIELD Analyzer InterX500 Flexible Array Electrode InterX5000

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HPT Perimeter, Automatic, Ac-Powered Ophthalmic Class 1 886.1605 2024-08-01
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2020-04-03
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2019-02-18
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2020-04-03
QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety Neurology Class 2 882.5800 2019-02-18

Official Correspondent

Todd Kingrey

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Morgan Newton Company
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008312728. Last updated year: 2026. Please use registration number 3008312728 when referencing this establishment in official correspondence.
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