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510(k) K121590

VESTIBULAR ANALYSIS APPARATUS by Capacity Sports, LLC — Product Code LXV

K121590 is an FDA 510(k) premarket notification submitted by Capacity Sports, LLC for the device "VESTIBULAR ANALYSIS APPARATUS". The FDA issued a decision of Substantially Equivalent on September 20, 2012. The device falls under product code LXV (Apparatus, Vestibular Analysis), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2012
Date Received
May 31, 2012
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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  • 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)
  • K102364 — NYDIAG 200 (December 23, 2010)
  • K082634 — VERTIGONE BPPV GOGGLE (April 7, 2009)
  • K081602 — DIZZYFIX (September 19, 2008)
  • K071973 — EPLEY OMNIAX (June 20, 2008)

FDA data resources