21 C.F.R. § 868.5260 Breathing circuit bacterial filter.
Title 21 - Food and Drugs
(a) Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart F—Therapeutic Devices
§ 868.5260 Breathing circuit bacterial filter.