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510(k) K071973

EPLEY OMNIAX by Vesticon — Product Code LXV

K071973 is an FDA 510(k) premarket notification submitted by Vesticon for the device "EPLEY OMNIAX". The FDA issued a decision of Substantially Equivalent on June 20, 2008. The device falls under product code LXV (Apparatus, Vestibular Analysis), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2008
Date Received
July 17, 2007
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

Other clearances for product code LXV

  • K220231 — GyroStim (April 27, 2022)
  • K200529 — Orion (August 12, 2020)
  • K192652 — TRV (May 27, 2020)
  • K183661 — ClearEdge Balance System (October 22, 2019)
  • K190735 — EQ Balance (August 16, 2019)
  • K173669 — K-D Balance (April 2, 2018)
  • K121590 — VESTIBULAR ANALYSIS APPARATUS (September 20, 2012)
  • K102364 — NYDIAG 200 (December 23, 2010)
  • K082634 — VERTIGONE BPPV GOGGLE (April 7, 2009)
  • K081602 — DIZZYFIX (September 19, 2008)

FDA data resources