21 CFR 868.5220
§ 868.5220 Blow bottle.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 868.5220, § 868.5220 Blow bottle, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89785
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Full text
(a) Identification. A blow bottle is a device that is intended for medical purposes to induce a forced expiration from a patient. The patient blows into the device to move a column of water from one bottle to another.
(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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.