Viterion Telehealthcare, LLC
Country not established
- Devices
- 1
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
What Viterion Telehealthcare, LLC makes
Viterion Telehealthcare, LLC manufactures the Viterion 100 Telehealth Monitor, a device designed for remote patient monitoring and telehealth applications. It is intended to collect and transmit vital signs data for clinical assessment and follow-up care.
The Viterion 100 Telehealth Monitor is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Viterion 100 Telehealth Monitor Ref K030419
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 4 recalls initiated by Viterion Telehealthcare, LLC, the earliest on 2011-05-25 and the most recent on 2012-11-15. By recorded status: 4 terminated. The reasons filed fall into these groups: 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.
2012
- 15 Nov 2012 Z-0820-2013 Class II Terminated Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek Advantage 03 and 04 meters to healthcare professionals.
- 15 Nov 2012 Z-0821-2013 Class II Terminated Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek Advantage 03 and 04 meters to healthcare professionals.
- 15 Nov 2012 Z-0822-2013 Class II Terminated Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek Advantage 03 and 04 meters to healthcare professionals.
2011
- 25 May 2011 Z-1036-2012 Unclassified (pre-2012) Terminated Software defect; Specifically, blood glucose (BG) results from the Roche Aviva meter that are tagged by the user with either the meter hypoglycemic or general "asterisk" flags (*) will not be automatically transmitted through the Viterion 100-BGM monitor containing software version 3.2.0 or displayed to the health care provider through the data server.
Frequently asked questions
How many devices does Viterion Telehealthcare, LLC have in the registry?
The registry currently lists 1 device for Viterion Telehealthcare, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Viterion Telehealthcare, LLC's devices?
Among its 1 most recently registered device, Viterion Telehealthcare, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Viterion Telehealthcare, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Viterion Telehealthcare, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Viterion Telehealthcare, LLC?
FDA recall records list 4 recalls initiated by Viterion Telehealthcare, LLC, the most recent initiated on 15 Nov 2012. 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 Viterion Telehealthcare, LLC in the registry?
The most recently registered devices listed for Viterion Telehealthcare, LLC include VITERION 100 TELEHEALTH MONITOR.