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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 K171038
Device Name Hearing Healthcare Pro
dB Diagnostic Systems, Inc.
17 Sachem Road
weston,  CT  06883
Applicant Contact steven levine
MEDIcept, Inc.
200 Homer Avenue
ashland,  MA  01721
Correspondent Contact robyn kressin
Regulation Number874.1090
Classification Product Code
Date Received04/06/2017
Decision Date 08/02/2017
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