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510(k) K935400

FONIX 3500 HEARING AID ANALYZER by Frye Electronics, Inc. — Product Code ETW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1994
Date Received
November 9, 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

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  • K895383 — TYPE FP40 DIGITAL HEARING AID ANALYZER (January 22, 1990)
  • K872242 — TYPE 6400 REAL EAR HEARING AID ANALYZER (July 10, 1987)
  • K861571 — TYPE 6500 HEARING AID ANALYZER (May 30, 1986)
  • K850918 — TYPE FP30 DIGITAL HEARING AID ANALYZER (May 29, 1985)
  • K833883 — DIGITAL AUDIOMETER/HEARING AID 3100 (February 21, 1984)

Other clearances for product code ETW

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  • 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)