21 CFR § 868.1910
Esophageal stethoscope
June 25, 2020
(a) Identification. An esophageal stethoscope is a nonpowered device that is inserted into a patient's esophagus to enable the user to listen to heart and breath sounds.
(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 §868.9.
[47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]
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