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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 |
§ 868.5640 - Medicinal nonventilatory nebulizer (atomizer).
Latest version.
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§ 868.5640 Medicinal nonventilatory nebulizer (atomizer).
(a) Identification. A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.
[47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]