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510(k) K033645

OTOFLEX 100 TYE 1012 by Gn Otometrics A/S — Product Code ETY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2004
Date Received
November 20, 2003
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 Gn Otometrics A/S

  • K161707 — Madsen Zodiac (September 1, 2016)
  • K151504 — ICS Impulse (November 16, 2015)
  • K143670 — ICS CHARTR EP 200 WITH VEMP (October 23, 2015)
  • K132957 — MADSEN ACCUSCREEN TYPE 1077 (February 27, 2014)
  • K122550 — ICS IMPULSE (February 1, 2013)
  • K122028 — AURICAL HIT (October 23, 2012)
  • K122067 — TYPE 1077 ACCUSCREEN (September 27, 2012)
  • K110286 — GN OTOMETRICS TYPE 1053 FREEFIT (April 28, 2011)
  • K092373 — ICS CHARTR EP 200 (September 3, 2009)
  • K083399 — ICS CHARTR EP 200 (February 20, 2009)

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)
  • 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)