21 CFR 868.5640
§ 868.5640 Medicinal nonventilatory nebulizer (atomizer).
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 868.5640, § 868.5640 Medicinal nonventilatory nebulizer (atomizer), United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89819
- Permanent ID
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aa8b6aa025260b5e8a0abe9227f3cb28624363fbe2774ef4325b2ce980942f5a
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.