CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 878—GENERAL AND PLASTIC SURGERY DEVICES > SUBPART F—Therapeutic Devices (§878.5070 to §878.5910) > 878.5070—Air-handling apparatus for a surgical operating room.

878.5070—Air-handling apparatus for a surgical operating room.

(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.