§ 868.1965. Switching valve (ploss).
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/us/cfr/t21/s§ 868.1965·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38793, July 25, 2001; 90 FR 55982, Dec. 4, 2025]