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510(k) K151616

AT235 by Interacoustics A/S — Product Code ETY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2015
Date Received
June 15, 2015
Clearance Type
Special
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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Other clearances for product code ETY

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  • K162210 — touchTymp (November 16, 2016)
  • K161707 — Madsen Zodiac (September 1, 2016)
  • 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)
  • K083861 — TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MOD (April 9, 2009)
  • K081841 — AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER (July 16, 2008)
  • K070312 — EARCHECK ACOUSTIC REFLECTOMETER (March 2, 2007)