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510(k) K183201

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2019
Date Received
November 19, 2018
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.

  • K171038 — Hearing Healthcare Pro (August 2, 2017)

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  • K133013 — INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE P (January 24, 2014)
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  • K081841 — AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER (July 16, 2008)
  • K070312 — EARCHECK ACOUSTIC REFLECTOMETER (March 2, 2007)