21 C.F.R. § 868.1900 Diagnostic pulmonary-function interpretation calculator.
Title 21 - Food and Drugs
(a) Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 868—ANESTHESIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 868.1900 Diagnostic pulmonary-function interpretation calculator.