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510(k) K083861

TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE by Interacoustics AS — Product Code ETY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2009
Date Received
December 24, 2008
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

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  • K173567 — Sera (February 14, 2018)
  • K163149 — VisualEyes (April 26, 2017)
  • K162037 — Eclipse with VEMP (March 23, 2017)
  • K152112 — VisualEyes (December 29, 2015)
  • K151616 — AT235 (July 15, 2015)
  • K131681 — EYESEECAM VHIT (September 6, 2013)

Other clearances for product code ETY

  • K183201 — Hearing Healthcare Pro (March 6, 2019)
  • K171038 — Hearing Healthcare Pro (August 2, 2017)
  • K162210 — touchTymp (November 16, 2016)
  • K161707 — Madsen Zodiac (September 1, 2016)
  • K151616 — AT235 (July 15, 2015)
  • K151509 — GSI TympStar Pro Middle Ear Analyzer (June 25, 2015)
  • K133013 — INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE P (January 24, 2014)
  • K121847 — TITAN (November 29, 2012)
  • K081841 — AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER (July 16, 2008)
  • K070312 — EARCHECK ACOUSTIC REFLECTOMETER (March 2, 2007)