Code of Federal Regulations (Last Updated: May 6, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 868 - Anesthesiology Devices |
Subpart B - Diagnostic Devices |
§ 868.1880 - Pulmonary-function data calculator.
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§ 868.1880 Pulmonary-function data calculator.
(a) Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.
(b) Classification. Class II (performance standards).