Earcheck

FDA 510(k) K971859 · Mdi Instruments, Inc.

Substantially Equivalent

510(k) numberK971859

Submission

Device name
Earcheck
Applicant
Mdi Instruments, Inc.
Woburn, MA, US
Received
May 20, 1997
Decision date
August 18, 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 cleared by the FDA?

Earcheck (K971859) received a 510(k) decision of Substantially Equivalent on August 18, 1997, 90 days after the submission was received.

What is the product code of K971859?

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