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510(k) K896477

NICOLET REAL EAR ANALYZER by Nicolet Instrument Corp. — Product Code ETW

K896477 is an FDA 510(k) premarket notification submitted by Nicolet Instrument Corp. for the device "NICOLET REAL EAR ANALYZER". The FDA issued a decision of Substantially Equivalent on February 8, 1990. The device falls under product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems), a Class II device regulated under 21 CFR 874.3310. Nicolet Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1990
Date Received
November 13, 1989
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 Nicolet Instrument Corp.

  • K921138 — NICOLET ULTRASOM ACQUISITION STATION (May 14, 1993)
  • K923315 — NICOLET ARK SYSTEM (November 23, 1992)
  • K921927 — NICOLET VOYAGEUR (November 5, 1992)
  • K915652 — NICOLET PORATBLE SPIRIT SYSTEM (February 7, 1992)
  • K905632 — NICOLET MAPLELEAF SYSTEM (June 7, 1991)
  • K897154 — NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE (April 30, 1990)
  • K894629 — NICOLET BEAM II SYSTEM (March 9, 1990)
  • K883781 — NICOLET NEUROPORT/ACE SYSTEM (June 5, 1989)
  • K890495 — NICOLET VIKING II SYSTEM (March 16, 1989)
  • K884294 — NICOLET NYSTAR PLUS SYSTEM (November 23, 1988)

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