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510(k) K041853

OTOGRAM by Tympany, Inc. — Product Code ETW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2004
Date Received
July 8, 2004
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 Tympany, Inc.

  • K070118 — OTOGRAM, CA3350 (March 7, 2007)

Other clearances for product code ETW

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  • 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)
  • 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)