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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 K183201
Device Name Hearing Healthcare Pro
Applicant
Db Diagnostic Systems, Inc.
17 Sachem Rd.
Weston,  CT  06883
Applicant Contact Steven Levine
Correspondent
MEDIcept, Inc.
200 Homer Ave.
Ashland,  MA  01721
Correspondent Contact Scott Blood
Regulation Number874.1090
Classification Product Code
ETY  
Date Received11/19/2018
Decision Date 03/06/2019
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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