21 C.F.R. § 868.1900

Diagnostic pulmonary-function interpretation calculator.

Last amended: 2016Year: 2026Length: 28 wordsSubsections: 1Official source

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).
21 C.F.R. § 868.1900: Diagnostic pulmonary-function interpretation calculator. | Justis AI