FDA-Device2013-02-20Class II
Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
Viterion TeleHealthcare Llc
Hazard
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.
Sold states
Worldwide Distribution-USA (nationwide) and the United Kingdom.
Affected count
Domestic - 7698 units
Manufactured in
555 White Plains Rd, Tarrytown, NY, United States
Products
Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0821-2013Don't want to check this manually?
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