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The Second Wind Air Purifier was designed to be used in an HVAC system, to improve the indoor air quality. The Second Wind air purifier is recommended to be used in conjunction with a media filter, humidifying device, proper controls to run the fan and the sealing of any ductwork. The Second Wind air purifier may be, but not necessarily used in conjunction with a complete IAQ package. The use is for anyone concerned with his or her indoor air quality. The unit is easily installed within the forced air furnace and/or the air movement device within a home or business.

Second Wind Air Purifier/First Breath Air Purifier Hotel, ultraviolet HVAC mounted

I am sorry, but based on the provided text, there is no information available regarding acceptance criteria for a device, nor any study proving the device meets said criteria.

The document is a 510(k) clearance letter from the FDA for a device called "First Breathe and Second Wind Air Purifier, Trade Name: Ultraviolet HVAC Mounted." This letter primarily addresses the regulatory status of the device, stating that it is "substantially equivalent" to devices marketed prior to May 28, 1976.

The indications for use are also mentioned: "The Second Wind Air Purifier was designed to be used in an HVAC system, to improve the indoor air quality. The Second Wind air purifier is recommended to be used in conjunction with a media filter, humidifying device, proper controls to run the fan and the sealing of any ductwork."

However, the document does not contain any data, study results, acceptance criteria, sample sizes, expert qualifications, or ground truth information that would allow me to answer your specific questions about device performance and the study demonstrating it.

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