Bio-Logic Insert Earphones

FDA 510(k) K031352 · Bio-Logic Systems Corp.

Substantially Equivalent

510(k) numberK031352

Submission

Device name
Bio-Logic Insert Earphones
Applicant
Bio-Logic Systems Corp.
Mudelein, IL, US
Received
April 29, 2003
Decision date
July 16, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EWO – Audiometer
Device class
Class II (moderate risk)
Regulation
21 CFR 874.1050
Specialty
Ear, Nose, Throat

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Questions and answers

When was Bio-Logic Insert Earphones cleared by the FDA?

Bio-Logic Insert Earphones (K031352) received a 510(k) decision of Substantially Equivalent on July 16, 2003, 78 days after the submission was received.

What is the product code of K031352?

The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.