Compumedics Okti
The Okti acquisition module collects physiological signals for EEG studies used to assist assessment of neurological disorders. It connects to an Okti base unit and works with Compumedics…
The Okti acquisition module collects physiological signals for EEG studies used to assist assessment of neurological disorders. It connects to an Okti base unit and works with Compumedics Profusion EEG software on a computer. The available modules provide 32, 64 or 128 referential EEG channels.
Each module contains electrode connectors and analogue circuitry, with additional differential inputs for signals such as ECG, EMG and eye movements. It converts the signals into digital data using 24-bit converters and applies digital filtering before passing the data to the base unit.
Listed Item
Okti 128 Channel Acquisition Module
Data and Setting
Through the Okti base unit, recordings can be stored on an internal memory card or sent to a computer by Ethernet or Wi-Fi. The equipment is intended for hospital or clinical EEG use and requires the compatible base unit and software.
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1), Shaanxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Compumedics Limited, Australia |
|---|---|
| FDA product code | GWQ |
| Device type | Full-Montage Standard Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K230073 |
| Record published | 2023-06-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Okti 128 | In distribution | |
| Okti 64 | In distribution | |
| Okti 32 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Natus | Xltek | 54 |
| Trackit | Lifelines Ltd. | 24 |
| Full-Montage Standard Electroencephalograph | Nihon Kohden Corp. | 20 |
| Enobio Dx | Neuroelectrics Barcelona SL | 19 |
| Compumedics Neuvo | Compumedics Limited | 19 |
| Natus | Natus Neurology Incorporated | 18 |
| X-Series | Advanced Brain Monitoring, Inc. | 16 |
| Full-Montage Standard Electroencephalograph | Nihon Kohden America, Inc. | 15 |
| Grass | Xltek | 13 |
| Seer Home | Seer Medical Pty, Ltd. | 10 |
| Compumedics SynAmps RT | Compumedics Limited | 9 |
| Component Neuromonitoring System | Moberg Research, Inc. | 9 |
Showing 12 of 131. All products under Full-Montage Standard Electroencephalograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230073 | 2023-02-09 |
| K093223 | 2010-01-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.