Home Article 3B Medical receives FDA approval for emergency use of certain devices

3B Medical receives FDA approval for emergency use of certain devices

3B Medical receives FDA approval for emergency use of certain devices

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By HME News Staff

Updated Fri April 17, 2020

WINTER HAVEN, Fla. - 3B Medical has received Emergency Use Authorization from the U.S. Food and Drug Administration for its High-Flow H80 System and its Luna BPAP ST non-invasive respiratory devices for use in the U.S. during the COVID-19 pandemic. “I am pleased that 3B Medical will be able to join the manufacturing industry's collective surge in production capacity to meet global shortages across the board for all therapeutic devices used to treat COVID-19 patients,” said Dr. Jose Llana, vice president of sales.

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