Who is the manufacturer of IL0292 DP ECHOPORT?

Smith submitted the Traditional clearance for IL0292 DP ECHOPORT (K970555).

What is the FDA product code for IL0292 DP ECHOPORT?

EWO. It is classified under 21 CFR 874.1050 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for IL0292 DP ECHOPORT?

510(k) clearance (submission type: Traditional).

IL0292 DP ECHOPORT

K970555 · Smith · EWO · Mar 17, 1997 · Ear, Nose, Throat

Device Facts

Record ID	K970555
Device Name	IL0292 DP ECHOPORT
Applicant	Smith
Product Code	EWO · Ear, Nose, Throat
Decision Date	Mar 17, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.1050
Device Class	Class 2

Regulatory Classification

Identification

An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.