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510(k) K122028

AURICAL HIT by Gn Otometrics — Product Code ETW

K122028 is an FDA 510(k) premarket notification submitted by Gn Otometrics for the device "AURICAL HIT". The FDA issued a decision of Substantially Equivalent on October 23, 2012. The device falls under product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems), a Class II device regulated under 21 CFR 874.3310. Gn Otometrics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2012
Date Received
July 10, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class
Class II
Regulation Number
874.3310
Review Panel
EN
Submission Type

Other clearances by Gn Otometrics

  • 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)
  • 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)
  • K081234 — GN OTOMETRICS INSERT EARPHONES (July 14, 2008)

Other clearances for product code ETW

  • K113831 — PRIMUS HEARING INSTRUMENT TEST UNIT (April 19, 2012)
  • K110286 — GN OTOMETRICS TYPE 1053 FREEFIT (April 28, 2011)
  • K093006 — FONIX ,MODEL 8000 (December 30, 2009)
  • K071462 — UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) (June 5, 2007)
  • K061104 — SPEECHLINK 100 TYPE 1053 (May 3, 2006)
  • K050496 — REM440 (April 29, 2005)
  • K041853 — OTOGRAM (September 3, 2004)
  • K022510 — FONIX, MODEL 7000 (August 27, 2002)
  • K012306 — AUDIOSCAN VERIFIT, MODEL VF-1 (September 21, 2001)
  • K980377 — FONIX FP35 HEARING AID ANALYZER (March 18, 1998)

FDA data resources