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21 C.F.R. § 868.1900 – Diagnostic pulmonary-function interpretation calculator. | Midpage
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Code of Federal Regulations
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Subchapter H
Part 868
Subpart B
§ 868.1900
21 C.F.R. § 868.1900
Diagnostic pulmonary-function interpretation calculator.
(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).