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510(k) K061104

SPEECHLINK 100 TYPE 1053 by Gn Otometrics A/S — Product Code ETW

K061104 is an FDA 510(k) premarket notification submitted by Gn Otometrics A/S for the device "SPEECHLINK 100 TYPE 1053". The FDA issued a decision of Substantially Equivalent on May 3, 2006. 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 A/S has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2006
Date Received
April 20, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 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 ETW

  • K122028 — AURICAL HIT (October 23, 2012)
  • 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)
  • 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