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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Auditory Impedance
510(k) Number K970685
FOIA Releasable 510(k) K970685
Device Name EARCHECK PRO
Applicant
Mdi Instruments, Inc.
200 Unicore Park Dr.
Woburn,  MA  01801
Applicant Contact SANDRA KIMBALL
Correspondent
Mdi Instruments, Inc.
200 Unicore Park Dr.
Woburn,  MA  01801
Correspondent Contact SANDRA KIMBALL
Regulation Number874.1090
Classification Product Code
ETY  
Date Received02/24/1997
Decision Date 05/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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