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510(k) K934342

GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM by Glaser Instruments AG — Product Code ETW

K934342 is an FDA 510(k) premarket notification submitted by Glaser Instruments AG for the device "GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on January 21, 1994. The device falls under product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems), a Class II device regulated under 21 CFR 874.3310. Glaser Instruments AG has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1994
Date Received
September 7, 1993
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 Glaser Instruments AG

  • K934343 — GLASER RT60, RT80, RT150 AUDIOMETER (January 21, 1994)

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)
  • 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)

FDA data resources