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510(k) K183661

ClearEdge Balance System by Quadrant Biosciences — Product Code LXV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2019
Date Received
December 27, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Vestibular Analysis
Device Class
Class U
Regulation Number
Review Panel
EN
Submission Type

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  • K121590 — VESTIBULAR ANALYSIS APPARATUS (September 20, 2012)
  • K102364 — NYDIAG 200 (December 23, 2010)
  • K082634 — VERTIGONE BPPV GOGGLE (April 7, 2009)
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