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510(k) K151504

ICS Impulse by Gn Otometrics — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2015
Date Received
June 4, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nystagmograph
Device Class
Class II
Regulation Number
882.1460
Review Panel
NE
Submission Type

Other clearances by Gn Otometrics

  • K161707 — Madsen Zodiac (September 1, 2016)
  • K143670 — ICS CHARTR EP 200 WITH VEMP (October 23, 2015)
  • K132957 — MADSEN ACCUSCREEN TYPE 1077 (February 27, 2014)
  • K122550 — ICS IMPULSE (February 1, 2013)
  • K122028 — AURICAL HIT (October 23, 2012)
  • K122067 — TYPE 1077 ACCUSCREEN (September 27, 2012)
  • K110286 — GN OTOMETRICS TYPE 1053 FREEFIT (April 28, 2011)
  • K092373 — ICS CHARTR EP 200 (September 3, 2009)
  • K083399 — ICS CHARTR EP 200 (February 20, 2009)
  • K081234 — GN OTOMETRICS INSERT EARPHONES (July 14, 2008)

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