21 CFR 868.2875
§ 868.2875 Differential pressure transducer.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 868.2875, § 868.2875 Differential pressure transducer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89766
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Full text
(a) Identification. A differential pressure transducer is a two-chambered device intended for medical purposes that is often used during pulmonary function testing. It generates an electrical signal for subsequent display or processing that is proportional to the difference in gas pressures in the two chambers.
(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.