Code of Federal Regulations · Section
§ 868.1840 — Diagnostic Spirometer
21 C.F.R. § 868.1840
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(a) Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351