21 CFR 868.5600
§ 868.5600 Venturi mask.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 868.5600, § 868.5600 Venturi mask, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89816
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Full text
(a) Identification. A venturi mask is a device containing an air-oxygen mixing mechanism that dilutes 100 percent oxygen to a predetermined concentration and delivers the mixed gases to a patient.
(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 the limitations in § 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.