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Code of Federal Regulations (Last Updated: October 10, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 868 - Anesthesiology Devices |
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Subpart C - Monitoring Devices |
§ 868.2350 - Gas calibration flowmeter.
Latest version.
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§ 868.2350 Gas calibration flowmeter.
(a) Identification. A gas calibration flowmeter is a device intended for medical purposes that is used to calibrate flowmeters and accurately measure gas flow.
(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.
[47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001]