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(Reuters) - The U.S. Food and Drug Administration (FDA) on Thursday classified the recall of certain respiratory masks made by ResMed as most serious as their use could cause major injuries or death.
McGinnis developed the "Nasal CPAP Mask System," a continuous positive airway pressure (CPAP) machine for the treatment of sleep apnea, [3] based on the original 1981 design by Dr. Colin Sullivan. [4] After receiving FDA approval in 1984, Respironics began selling the first commercially available CPAP machine a year later. [5]
ResMed Inc. is an American medical equipment company based in San Diego, California.It primarily provides cloud-connectable medical devices for the treatment of sleep apnea (such as CPAP devices and masks), chronic obstructive pulmonary disease (COPD), and other respiratory conditions.
After selling the company, McGinnis founded another medical device company called Respironics in 1976. In the early 1980s, the company developed a CPAP machine called the SleepEasy, receiving FDA approval in 1984. The machines were a commercial success and helped establish Respironics as a major player in the medical device industry. [3]
The Amsterdam-based healthcare technology company has been grappling with the fallout of a global recall in June 2021 of millions of respirators used to treat sleep apnea over worries that foam ...
The FDA defines a recall as a method of removing or correcting products that are in violation of laws administered by the health regulator and does not include a market withdrawal. ResMed's masks ...
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