Esophageal stethoscope with electrical conductors.

21 C.F.R. § 868.1920
in effectEffective: 2024-07-01
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(a) Identification. An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement. (b) Classification. Class II (performance standards).

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