21 CFR 868.1920 — Stethoscope, Esophageal, With Electrical Conductors
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1920
Identification
An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 2 | 46 | 3rd Party |
