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510(k) K163558

Synapsys Ulmer Video Nystagmograph by Synapsys SA — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2017
Date Received
December 19, 2016
Clearance Type
Special
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 Synapsys SA

  • K012415 — AURIS AEP (December 18, 2001)
  • K982103 — ULMER (VNG) VIDEO NYSTAGMOGRAPH (September 11, 1998)

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