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510(k) K131681

EYESEECAM VHIT by Interacoustics A/S — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2013
Date Received
June 10, 2013
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

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  • K173567 — Sera (February 14, 2018)
  • K163149 — VisualEyes (April 26, 2017)
  • K162037 — Eclipse with VEMP (March 23, 2017)
  • K152112 — VisualEyes (December 29, 2015)
  • K151616 — AT235 (July 15, 2015)
  • K130795 — TITAN (June 20, 2013)

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