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510(k) K081602

DIZZYFIX by Clearwater Clinical Limited — Product Code LXV

K081602 is an FDA 510(k) premarket notification submitted by Clearwater Clinical Limited for the device "DIZZYFIX". The FDA issued a decision of Substantially Equivalent on September 19, 2008. The device falls under product code LXV (Apparatus, Vestibular Analysis), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2008
Date Received
June 6, 2008
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)
  • K071973 — EPLEY OMNIAX (June 20, 2008)

FDA data resources