Ethical Hearing Instruments/Wizard Hearing Profile Tester

FDA 510(k) K962012 · Ethical Hearing Instruments

Substantially Equivalent

510(k) numberK962012

Submission

Device name
Ethical Hearing Instruments/Wizard Hearing Profile Tester
Applicant
Ethical Hearing Instruments
Portsmouth, NH, US
Received
May 23, 1996
Decision date
August 21, 1996
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 Ethical Hearing Instruments/Wizard Hearing Profile Tester cleared by the FDA?

Ethical Hearing Instruments/Wizard Hearing Profile Tester (K962012) received a 510(k) decision of Substantially Equivalent on August 21, 1996, 90 days after the submission was received.

What is the product code of K962012?

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