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Code of Federal Regulations (Last Updated: October 10, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 868 - Anesthesiology Devices |
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Subpart B - Diagnostic Devices |
§ 868.1840 - Diagnostic spirometer.
Latest version.
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§ 868.1840 Diagnostic spirometer.
(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).