Home / 510(k) Clearances / K070312

510(k) K070312

EARCHECK ACOUSTIC REFLECTOMETER by Innovia Medical, LLC — Product Code ETY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2007
Date Received
February 1, 2007
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

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)