21 CFR 874.1925 — Tube, Toynbee Diagnostic
Ear, Nose, Throat (EN) · Part 874 Subpart B—Diagnostic Devices · § 874.1925
Identification
The toynbee diagnostic tube is a listening device intended to determine the degree of openness of the eustachian tube.
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 § 874.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ETK | Tube, Toynbee Diagnostic | 1 | 1 |