Code of Federal Regulations · Section

§ 868.1900 — Diagnostic Pulmonary-function Interpretation Calculator

21 C.F.R. § 868.1900

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(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. § 868.1890 21 C.F.R. § 868.1910

Authorizing Statute