Medical Devices

U.S. FDA grants 510(k) approval for sale, distribution of anesthesia systems in U.S. market

Published in Biotech Business Week, November 7th, 2005

Blease Medical, a division of OSI Systems, Inc., (OSIS), announced that it had received 510(k) from the U.S. Food and Drug Administration (FDA) for the sale of its Sirius 3000 with 8700 ventilator, anesthesia system into the United States market.

Currently, Blease distributes a complete range of anesthesia systems and ventilators internationally to approximately 90 countries but not currently to the United States. FDA 510(k) approval clears the way for the company's flagship system to be sold in the United States, where annual sales of anesthesia systems and ventilators is approximately $429 million, as estimated by independent business consultants, Frost &...

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Source: Biotech Business Week (2005-11-07)

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