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510(k) K851744

EQUITEST by Neurocom International, Inc. — Product Code LXV

K851744 is an FDA 510(k) premarket notification submitted by Neurocom International, Inc. for the device "EQUITEST". The FDA issued a decision of Substantially Equivalent on August 5, 1985. The device falls under product code LXV (Apparatus, Vestibular Analysis), a Class U device. Neurocom International, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1985
Date Received
April 29, 1985
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 Neurocom International, Inc.

  • K946229 — BALANCE MANAGER (August 4, 1995)
  • K901732 — EMG ACCESSORY FOR POSTUROGRAPHY (September 10, 1991)
  • K871652 — NEUROCOM PRESSURE TEST SYSTEM (July 16, 1987)
  • K863443 — DUAL FORCEPLATE (September 17, 1986)

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