21 C.F.R. § 868.1900
Diagnostic pulmonary-function interpretation calculator.
Cite as 21 C.F.R. § 868.1900 (2026)
(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).