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Code of Federal Regulations (Last Updated: July 5, 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 |
§ 868.5895 - Continuous ventilator.
Latest version.
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§ 868.5895 Continuous ventilator.
(a) Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
(b) Classification. Class II (performance standards).