Cleared Traditional

Hearing Healthcare Pro

K171038 · Db Diagnostic Systems, Inc. · Ear, Nose, Throat

Aug 2017

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K171038 is an FDA 510(k) clearance for the Hearing Healthcare Pro, a Tester, Auditory Impedance (Class II — Special Controls, product code ETY), submitted by Db Diagnostic Systems, Inc. (Weston, US). The FDA issued a Cleared decision on August 2, 2017, 118 days after receiving the submission on April 6, 2017. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1090.

Submission Details

510(k) Number	K171038 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2017
Decision Date	August 02, 2017
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF