21 CFR 868.1910 — Stethoscope, Esophageal
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 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 Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BZW | Stethoscope, Esophageal | 1 | 13 |
