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Mindray ultrasound, analyzer gain 510(k)s

This article was originally published in The Gray Sheet

Executive Summary

Shenzhen, China-based patient monitoring, life support, in-vitro diagnostic and medical imaging firm announces March 31 the U.S. and international availability of its portable M5 ultrasound imaging system and BS-200 automatic bio-chemistry analyzer. The six-kilogram M5 is the company's first laptop-size ultrasound imaging device. BS-200 is an automatic, low-throughput bio-chemistry analyzer designed to replace semi-automatic analyzers, and is targeted to rural hospitals and labs in China and other international markets. Mindray also submitted late last year for FDA sign-off for three BeneView multi-parameter patient monitoring devices, and it expects Chinese approval by July for its EX55 and EX65 compact anesthesia machines
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