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 CodeDevice NameClassDevicesAttributes
ETKTube, Toynbee Diagnostic11
Innolitics

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