Authorization

OXYNOV ANNOUNCES 510(k) SUBMISSION TO U.S. FDA FOR ITS FREEO2a?? DEVICE

QUEBEC CITY, Sept. 28, 2022 /PRNewswire/ - OxyNov Inc. has filed a 510(k) submission with the U.S. Food and Drug Administration (FDA) for the FreeO2a?? device, an oxygen therapy device developed by the company itself.The FDA is a U.S. government agency responsible for protecting the public health by ensuring the safety, efficacy, and security of medical devices, among other things. FDA is also responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable.This 510(k) submission by OxyNov is an important step in obtaining marketing authorization in the United States for the FreeO2a?? device."Today marks an important milestone in our commitment to our customers and patients to advance the world of healthcare," said Patrice Allibert, PhD, President and CEO of OxyNov.The application is currently under review by the FDA, and the process is expected to take several months. While waiting for FDA clearance, OxyNov is continuing its preparations for the launch of the FreeO2a?? device in the United States.
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