§868.1910. Esophageal stethoscope.
21 C.F.R. § 868.1910
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.
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.
Notes, amendments, and revision history
Amendments
[47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 47 FR 31142, July 16, 1982, unless otherwise noted.
Amendments
[47 FR 31142, July 16, 1982, as amended at 65 FR 2313, Jan. 14, 2000]