Code of Federal Regulations · Section
§ 868.1890 — Predictive Pulmonary-function Value Calculator
21 C.F.R. § 868.1890
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(a) Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351