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Code of Federal Regulations (Last Updated: November 8, 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 F - Therapeutic Devices |
§ 868.5915 - Manual emergency ventilator.
Latest version.
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§ 868.5915 Manual emergency ventilator.
(a) Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.
(b) Classification. Class II (performance standards).