21 C.F.R. § 878.5070 Air-handling apparatus for a surgical operating room.
Title 21 - Food and Drugs
(a) Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient. (b) Classification. Class II.
Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart F—Therapeutic Devices
§ 878.5070 Air-handling apparatus for a surgical operating room.
