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510(k) K020800

OPTAX SYSTEM by Optax Systems, Inc. — Product Code LQD

K020800 is an FDA 510(k) premarket notification submitted by Optax Systems, Inc. for the device "OPTAX SYSTEM". The FDA issued a decision of Substantially Equivalent on June 10, 2002. The device falls under product code LQD (Recorder, Attention Task Performance), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2002
Date Received
March 12, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Attention Task Performance
Device Class
Class U
Regulation Number
Review Panel
NE
Submission Type

Other clearances for product code LQD

  • K173915 — Test of Variables of Attention (T.O.V.A.) (March 22, 2018)
  • K170082 — Test of Variables of Attention (T.O.V.A.) Version 9.0 (May 17, 2017)
  • K143468 — QbCheck (March 22, 2016)
  • K141865 — DANA (October 15, 2014)
  • K133382 — QB TEST (March 24, 2014)
  • K122149 — QBTES (October 17, 2012)
  • K040894 — QBTEST (June 22, 2004)
  • K911938 — DYNAVISION 2000 (August 2, 1991)
  • K861304 — FAGAN TEST MACHINE FOR INFANT INTELLIGENCE (September 23, 1986)
  • K854903 — GORDON DIAGNOSTIC SYSTEM MODEL I (June 2, 1986)

FDA data resources