21 CFR 868.5620

§ 868.5620 Breathing mouthpiece.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 868.5620, § 868.5620 Breathing mouthpiece, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89817
Permanent ID: ys:prov:89817@1
SHA-256: 0b55e71730e1933c0bfbd4e293d84f80e476ae4dda48d9448c725f2825c1bc3b

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Full text

(a) Identification. A breathing mouthpiece is a rigid device that is inserted into a patient's mouth and that connects with diagnostic or therapeutic respiratory devices. (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.