Code of Federal Regulations (Last Updated: May 6, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 868 - Anesthesiology Devices |
Subpart B - Diagnostic Devices |
§ 868.1575 - Gas collection vessel.
Latest version.
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§ 868.1575 Gas collection vessel.
(a) Identification. A gas collection vessel is a container-like device intended to collect a patient's exhaled gases for subsequent analysis. It does not include a sampling pump.
(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 38793, July 25, 2001]