Health & Saf. Code, § 41985.5

For purposes of this article, the following terms have the following meanings:

(a) “Federal ozone emissions limit for air cleaning devices” means the level of generation of ozone above which the device would be considered adulterated or misbranded pursuant to Section 801.415 of Title 21 of the Code of Federal Regulations, specifically the generation of ozone at a level in excess of 0.05 part per million by volume of air circulating through the device or causing an accumulation of ozone in excess of 0.05 part per million by volume of air when measured under standard conditions at 25 degrees Celsius (77 degrees Fahrenheit) and 760 millimeters of mercury in the atmosphere of enclosed space intended to be occupied by people for extended periods of time.

(b) “Medical device” means “device” as defined in subsection (h) of Section 321 of Title 21 of the United States Code.