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510(k) K922037

SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR by Micromedical Technologies, Inc. — Product Code LXV

K922037 is an FDA 510(k) premarket notification submitted by Micromedical Technologies, Inc. for the device "SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR". The FDA issued a decision of Substantially Equivalent on October 26, 1992. 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
October 26, 1992
Date Received
May 1, 1992
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)
  • K891008 — VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ) (May 31, 1989)
  • 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