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510(k) K102364

NYDIAG 200 by Interacoustics A/S — Product Code LXV

K102364 is an FDA 510(k) premarket notification submitted by Interacoustics A/S for the device "NYDIAG 200". The FDA issued a decision of Substantially Equivalent on December 23, 2010. The device falls under product code LXV (Apparatus, Vestibular Analysis), a Class U device. Interacoustics A/S has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2010
Date Received
August 20, 2010
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 by Interacoustics A/S

  • K200534 — VisualEyes (August 12, 2020)
  • K200529 — Orion (August 12, 2020)
  • K192652 — TRV (May 27, 2020)
  • K191372 — Lyra (July 15, 2019)
  • K173567 — Sera (February 14, 2018)
  • K163149 — VisualEyes (April 26, 2017)
  • K162037 — Eclipse with VEMP (March 23, 2017)
  • K152112 — VisualEyes (December 29, 2015)
  • K151616 — AT235 (July 15, 2015)
  • K131681 — EYESEECAM VHIT (September 6, 2013)

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)
  • K082634 — VERTIGONE BPPV GOGGLE (April 7, 2009)
  • K081602 — DIZZYFIX (September 19, 2008)
  • K071973 — EPLEY OMNIAX (June 20, 2008)

FDA data resources