Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1650946

FEI Number

3002716534

Entity Name

COMPUMEDICS USA, INC.

City/State/Country

Charlotte, NC, US

Establishment Address

5015 West WT Harris Blvd, Suite E, Charlotte, NC 28269, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

Compumedics USA Inc. (Owner Number: 9029712)

Owner / Operator Contact Address

5015 W W.T. Harris Blvd, Suite E, Charlotte, NC 28269, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K001781

PMA Number

N/A

All Registered Proprietary Names

SOURCE software NEUVO QUIK-GEL Compumedics Somte System Compumedics Grael System QUIK-CAP Falcon HST SYNAMPS 2/RT Okti 32 Ch Ambulatory EEG Recorder Only Okti 64 Ch Ambulatory EEG System Okti 128 Ch Ambulatory EEG Recorder Only Okti Ethernet Connection Kit Okti 64 Ch Ambulatory EEG Recorder Only Okti 32 Ch Ambulatory EEG System Okti 128 Ch Ambulatory EEG System Somfit D CURRY software

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLX	Source Localization Software For Electroencephalograph Or Magnetoencephalograph	Neurology	Class 2	882.1400	2008-01-24
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2010-12-16
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2010-12-16
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2010-12-16
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2010-12-16
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2008-01-24
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2023-12-04
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2023-12-04
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2023-12-04
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2023-12-04
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2008-01-24
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2025-12-09
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2025-12-09
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2025-12-09
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2008-01-24
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2023-12-04
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2025-12-09
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2025-12-09
OLX	Source Localization Software For Electroencephalograph Or Magnetoencephalograph	Neurology	Class 2	882.1400	2008-01-24

Official Correspondent

Bailey Lewis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Compumedics USA Inc.

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
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02
K161650	Neurotronics, Inc.	Polysmith Sleep System, Model NTI7593	2017-01-19
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

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.
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

Similar Registrations

Registration Number	Establishment Name	Location
3014137562	RICOH COMPANY, LTD.	Kanazawa Ishikawa, JP
9680891	MEGIN OY	Espoo Uusimaa, FI
3033708293	BELCO. LLC	Eugene, OR, US
2031720	PERSYST DEVELOPMENT LLC	Solana Beach, CA, US
3017666517	MAGSTIM INC	Eugene, OR, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1650946. Last updated year: 2026. Please use registration number 1650946 when referencing this establishment in official correspondence.