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510(k) K200529

Orion by Interacoustics A/S — Product Code LXV

K200529 is an FDA 510(k) premarket notification submitted by Interacoustics A/S for the device "Orion". The FDA issued a decision of Substantially Equivalent on August 12, 2020. 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
August 12, 2020
Date Received
March 2, 2020
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)
  • 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)
  • K130795 — TITAN (June 20, 2013)

Other clearances for product code LXV

  • K220231 — GyroStim (April 27, 2022)
  • 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)
  • K071973 — EPLEY OMNIAX (June 20, 2008)

FDA data resources