Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613619

FEI Number

3004674371

Entity Name

COMPUMEDICS LIMITED

City/State/Country

Melbourne Victoria, AU

Establishment Address

30-40 Flockhart Street,, Abbotsford,, Melbourne Victoria 3067, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Compumedics (Owner Number: 10027560)

Owner / Operator Contact Address

30-40 Flockhart Street, Abbotsford, AU-VIC 3067, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K021176

PMA Number

N/A

All Registered Proprietary Names

QUIK-CAP Compumedics Siesta System Okti 32 Ch Ambulatory EEG System Okti 64 Ch Ambulatory EEG Recorder Only Okti 128 Ch Ambulatory EEG Recorder Only Okti Ethernet Connection Kit Okti 64 Ch Ambulatory EEG System Okti 128 Ch Ambulatory EEG System Okti 32 Ch Ambulatory EEG Recorder Only Quik Gel, EEG Electrodeconductive Gel Falcon HST Somfit D Somfit Compumedics Somte PSG System Orion LifeSpan MEG Neuvo Compumedics Grael System Synamps2/RT Compumedics Somte System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2023-09-14
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2008-11-17
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2008-11-17
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2023-02-20
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2023-09-14
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2025-02-23
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2025-02-23
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2025-02-23
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2025-09-04
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2025-09-04
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2024-01-04
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2024-01-04
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2008-11-17
OLY	Magnetoencephalograph	Neurology	Class 2	882.1400	2020-02-18
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2023-06-15
GWE	Stimulator, Photic, Evoked Response	Neurology	Class 2	882.1890	2023-06-15
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2023-06-15
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2023-06-15
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2010-12-16
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2010-12-16
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2010-12-16
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2023-06-15
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2008-11-17

Official Correspondent

John Joseph

US Agent Details

Bailey Lewis Business: Compumedics USA Ltd Email: quality@compumedics.com.au Phone: (704) 7493200

Related Public Records

Same Entity

Compumedics

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.
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

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3004695199	INCEREB LTD	Dublin Dun Laoghaire-Rathdown, IE
3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
9616086	DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613619. Last updated year: 2026. Please use registration number 9613619 when referencing this establishment in official correspondence.