Title 21

SECTION 878.5070

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 (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

[53 FR 23872, June 24, 1988, as amended at 84 FR 71814, Dec. 30, 2019]

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