Cleared Traditional

Hearing Healthcare Pro

K183201 · Db Diagnostic Systems, Inc. · Ear, Nose, Throat

Mar 2019

Decision

107d

Days

Class 2

Risk

About This 510(k) Submission

K183201 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 March 6, 2019, 107 days after receiving the submission on November 19, 2018. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1090.

Submission Details

510(k) Number	K183201 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 2018
Decision Date	March 06, 2019
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF