Earcheck Pro

FDA 510(k) K970685 · Mdi Instruments, Inc.

Substantially Equivalent

510(k) numberK970685

Submission

Device name
Earcheck Pro
Applicant
Mdi Instruments, Inc.
Woburn, MA, US
Received
February 24, 1997
Decision date
May 28, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ETY – Tester, Auditory Impedance
Device class
Class II (moderate risk)
Regulation
21 CFR 874.1090
Specialty
Ear, Nose, Throat

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Questions and answers

When was Earcheck Pro cleared by the FDA?

Earcheck Pro (K970685) received a 510(k) decision of Substantially Equivalent on May 28, 1997, 93 days after the submission was received.

What is the product code of K970685?

The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.