Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2184161

FEI Number

1000139867

Entity Name

Ducommun LaBarge Technologies

City/State/Country

APPLETON, WI, US

Establishment Address

2222 E Pensar Dr, APPLETON, WI 54911, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Ducommun LaBarge Technologies (Owner Number: 10041355)

Owner / Operator Contact Address

2222 E. Pensar Dr., Appleton, WI 54911, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Carefusion Nicolet EDX (Synergy) MPR Tx Proxy Somno Star & Series Sleep System Cortical Stimulator Quantum Electromyography Stimulator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2015-03-24
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2015-03-24
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2015-03-24
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2015-03-24
GZP	Stimulator, Mechanical, Evoked Response	Neurology	Class 2	882.1880	2015-03-24
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2015-03-24
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2015-03-24
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2017-03-31
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2018-05-29
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2015-03-12
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2015-03-12
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2018-03-12
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2018-03-12
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2018-03-12
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2025-01-28
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2025-01-28
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2025-01-28
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2025-01-28
GZP	Stimulator, Mechanical, Evoked Response	Neurology	Class 2	882.1880	2025-01-28
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2025-01-28
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2025-01-28

Official Correspondent

Kenneth Jones

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ducommun LaBarge Technologies

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
K880088	Cadwell Laboratories, Inc.	CADWELL EXCEL	1988-05-04
K033010	Brainz Instruments , Ltd.	BRM2 BRAIN MONITOR	2003-10-10
K991012	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY EEG POD	1999-06-24
K852587	Tracor Northern, Inc.	CDSA(COLOR DENSITY, SPECTRAL ARRRAY)	1985-08-16
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Z-0023-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020	Stryker Instruments Div. of Stryker Corporation	2	C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
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 2184161. Last updated year: 2026. Please use registration number 2184161 when referencing this establishment in official correspondence.