21 CFR 868.1910
§ 868.1910 Esophageal stethoscope.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 868.1910, § 868.1910 Esophageal stethoscope, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89738
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.