Cybernet Systems Co., Ltd.
Austin, TX, US
Cybernet Systems Co., Ltd. appears in FDA device records in Austin, TX. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Cybernet Systems Co., Ltd. in 2012.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0855-2010 | Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-381. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line. | 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. | Terminated | ||
| Z-0854-2010 | Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-386. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line. | 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. | Terminated | ||
| Z-0853-2010 | Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-380. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line. | 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. | Terminated | ||
| Z-0852-2010 | Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-210. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line. | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain