21 CFR 868.6400
§ 868.6400 Calibration gas.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 868.6400, § 868.6400 Calibration gas, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89857
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Full text
(a) Identification. A calibration gas is a device consisting of a container of gas of known concentration intended to calibrate medical gas concentration measurement 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 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.