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510(k) K980377

FONIX FP35 HEARING AID ANALYZER by Frye Electronics, Inc. — Product Code ETW

K980377 is an FDA 510(k) premarket notification submitted by Frye Electronics, Inc. for the device "FONIX FP35 HEARING AID ANALYZER". The FDA issued a decision of Substantially Equivalent on March 18, 1998. The device falls under product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems), a Class II device regulated under 21 CFR 874.3310. Frye Electronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1998
Date Received
February 2, 1998
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 Frye Electronics, Inc.

  • K123701 — HEARLAB ACA (April 5, 2013)
  • K093006 — FONIX ,MODEL 8000 (December 30, 2009)
  • K022510 — FONIX, MODEL 7000 (August 27, 2002)
  • K935400 — FONIX 3500 HEARING AID ANALYZER (January 14, 1994)
  • K913221 — TYPE FA10 AUDIOMETER (October 11, 1991)
  • 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

  • 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