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510(k) K891008

VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ) by Micromedical Technologies, Inc. — Product Code LXV

K891008 is an FDA 510(k) premarket notification submitted by Micromedical Technologies, Inc. for the device "VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)". The FDA issued a decision of Substantially Equivalent on May 31, 1989. The device falls under product code LXV (Apparatus, Vestibular Analysis), a Class U device. Micromedical Technologies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1989
Date Received
March 3, 1989
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 Micromedical Technologies, Inc.

  • K964325 — VISUALEYES: VIDEO EYE MONITOR (July 15, 1997)
  • K964646 — VIDEO EYE TRAKKER (July 15, 1997)
  • K922037 — SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR (October 26, 1992)
  • K863424 — COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE (March 23, 1987)

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