21 CFR 868.1965
§ 868.1965 Switching valve (ploss).
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 868.1965, § 868.1965 Switching valve (ploss), United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89741
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Full text
(a) Identification. A switching valve (ploss) is a three-way valve located between a stethoscope placed over the heart, a blood pressure cuff, and an earpiece. The valve allows the user to eliminate one sound channel and listen only to a patient's heart or korotkoff (blood pressure) sounds through the other channel.
(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. The device is also 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.