§ 868.1910. Esophageal stethoscope.
70 words·~1 min read·
/us/cfr/t21/s§ 868.1910·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]