21 C.F.R. § 868.1840 Diagnostic spirometer.
Title 21 - Food and Drugs
(a) Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 868.1840 Diagnostic spirometer.