Cybernet Systems Co., Ltd.
Country not established
- Devices
- 1
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
What Cybernet Systems Co., Ltd. makes
Cybernet Systems Co., Ltd. manufactures the DIRECTPATH, a medical device designed for direct neural interface applications, enabling communication between the brain and external systems.
The DIRECTPATH is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Directpath Ref K121449
510(k) 510(k)
FDA recalls
FDA recall records list 4 recalls initiated by Cybernet Systems Co., Ltd., initiated on 2008-01-23. By recorded status: 4 terminated. The reasons filed fall into these groups: labeling or instructions for use and software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 23 Jan 2008 Z-0852-2010 Unclassified (pre-2012) Terminated A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.
Full distribution text
- 23 Jan 2008 Z-0853-2010 Unclassified (pre-2012) Terminated A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.
Full distribution text
- 23 Jan 2008 Z-0854-2010 Unclassified (pre-2012) Terminated A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.
Full distribution text
- 23 Jan 2008 Z-0855-2010 Unclassified (pre-2012) Terminated A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.
Full distribution text
- 23 Jan 2008 Z-0852-2010 Unclassified (pre-2012) Terminated A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.
Frequently asked questions
How many devices does Cybernet Systems Co., Ltd. have in the registry?
The registry currently lists 1 device for Cybernet Systems Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cybernet Systems Co., Ltd.'s devices?
Among its 1 most recently registered device, Cybernet Systems Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Cybernet Systems Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Cybernet Systems Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Cybernet Systems Co., Ltd.?
FDA recall records list 4 recalls initiated by Cybernet Systems Co., Ltd., the most recent initiated on 2008-01-23. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Cybernet Systems Co., Ltd. in the registry?
The most recently registered devices listed for Cybernet Systems Co., Ltd. include DIRECTPATH.