Home / 510(k) Clearances / K113831

510(k) K113831

PRIMUS HEARING INSTRUMENT TEST UNIT by Auditdata A/S — Product Code ETW

K113831 is an FDA 510(k) premarket notification submitted by Auditdata A/S for the device "PRIMUS HEARING INSTRUMENT TEST UNIT". The FDA issued a decision of Substantially Equivalent on April 19, 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2012
Date Received
December 27, 2011
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 for product code ETW

  • K122028 — AURICAL HIT (October 23, 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