Regulatory & Medical

There is no statu­to­ry def­i­n­i­tion of Med­ical Device. 21 U.S. Code § 321 defines only a device. The phrase med­ical...

LiveO2 does not use Pos­i­tive Pres­sure because: Pos­i­tive pres­sure would inhib­it gas exchange in the lungs and reduce waste gas...