Home / 510(k) Clearances / K863353

510(k) K863353

MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER) by Grason-Stadler, Inc. — Product Code ETY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1986
Date Received
August 29, 1986
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 Grason-Stadler, Inc.

  • K180287 — GSI Corti (May 11, 2018)
  • K172403 — GSI Novus (October 20, 2017)
  • K000097 — GSI 2000 MIDDLE EAR ANALYZER (April 12, 2000)
  • K974237 — GSI 70 AUDIOPATH SCREENER (February 10, 1998)
  • K970324 — GSI SA60 DPOAE SYSTEM (June 6, 1997)
  • K953684 — GSI 61 CLINICAL AUDIOMETER (October 27, 1995)
  • K951759 — GSI 65 COMPUTERIZED AUDIOMETER (July 6, 1995)
  • K902540 — GSI 17 SCREENING AUDIOMETER (July 13, 1990)
  • K890124 — ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER (July 14, 1989)
  • K870030 — THE SCREENER GSI 55 ABR SCREENER (March 13, 1987)

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)