Esophageal stethoscope.

21 C.F.R. § 868.1910
in effectEffective: 2024-07-01
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(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.

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