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510(k) K183661

ClearEdge Balance System by Quadrant Biosciences — Product Code LXV

K183661 is an FDA 510(k) premarket notification submitted by Quadrant Biosciences for the device "ClearEdge Balance System". The FDA issued a decision of Substantially Equivalent on Oct 22, 2019. The device falls under product code LXV (Apparatus, Vestibular Analysis), a Class U device.

Clearance Details

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

Device Classification

Device Name
Apparatus, Vestibular Analysis
Device Class
Class U
Review Panel
EN
Submission Type
510(k)

Other clearances for product code LXV

  • K220231 — GyroStim (Apr 27, 2022)
  • K200529 — Orion (Aug 12, 2020)
  • K192652 — TRV (May 27, 2020)
  • K190735 — EQ Balance (Aug 16, 2019)
  • K173669 — K-D Balance (Apr 2, 2018)
  • K121590 — VESTIBULAR ANALYSIS APPARATUS (Sep 20, 2012)
  • K102364 — NYDIAG 200 (Dec 23, 2010)
  • K082634 — VERTIGONE BPPV GOGGLE (Apr 7, 2009)
  • K081602 — DIZZYFIX (Sep 19, 2008)
  • K071973 — EPLEY OMNIAX (Jun 20, 2008)

FDA data resources