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21 CFR 868.1900

§ 868.1900 Diagnostic pulmonary-function interpretation calculator.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 868.1900, § 868.1900 Diagnostic pulmonary-function interpretation calculator, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89737
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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).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.