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510(k) K171038

Hearing Healthcare Pro by Db Diagnostic Systems, Inc. — Product Code ETY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2017
Date Received
April 6, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Auditory Impedance
Device Class
Class II
Regulation Number
874.1090
Review Panel
EN
Submission Type

Other clearances by Db Diagnostic Systems, Inc.

  • K183201 — Hearing Healthcare Pro (March 6, 2019)

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  • K081841 — AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER (July 16, 2008)
  • K070312 — EARCHECK ACOUSTIC REFLECTOMETER (March 2, 2007)