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510(k) K200534

VisualEyes by Interacoustics A/S — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2020
Date Received
March 2, 2020
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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  • K152112 — VisualEyes (December 29, 2015)
  • K151616 — AT235 (July 15, 2015)
  • K131681 — EYESEECAM VHIT (September 6, 2013)
  • K130795 — TITAN (June 20, 2013)

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