ETK · Tube, Toynbee Diagnostic
Ear, Nose, Throat · 21 CFR 874.1925 · Class 1
Overview
| Product Code | ETK |
|---|---|
| Device Name | Tube, Toynbee Diagnostic |
| Regulation | 21 CFR 874.1925 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K823774 | WILSON EUSTACHIAN TUBAL, SONOGRAPH | Antares Technical Associates, Inc. | Jan 17, 1983 | SESE |
Top Applicants
- Antares Technical Associates, Inc. — 1 clearance
