Exemption decision due for medical oxygen device


Ingen Technologies Inc, a US medical device manufacturer, has announced that its OxyAlert oxygen delivery monitoring technology is undergoing assessment with the Food & Drug Administration (FDA) and is expected to receive an exempt status from the 510(k) filing in the next month.

OxyAlert is a new medical technology that uses wireless communication to send information related to the status of an oxygen delivery system to a remote receiver. The technology complies with the medical standards for wireless communication and at the same time, provides patients with the ability to distance themselves from the oxygen delivery system and still monitor the amount being delivered.

Thomas Neavit, chief financial officer (CFO), commented, “After several months of evaluation, the company is expected to receive an exemption from acquiring the 510(k) FDA requirement for OxyAlert. This allows OxyAlert to be immediately marketed through our exclusive distributor, Invacare Supply Group Inc.”

The Invacare Supply Group formalised a master distributor agreement with Ingen in August, to exclusively distribute its innovative new oxygen flow meter for a term of up to 3 years, including the North America, South America, Europe, Asia, Australia and New Zealand territories.

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