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510(k) K173915

Test of Variables of Attention (T.O.V.A.) by The Tova Company — Product Code LQD

K173915 is an FDA 510(k) premarket notification submitted by The Tova Company for the device "Test of Variables of Attention (T.O.V.A.)". The FDA issued a decision of Substantially Equivalent on March 22, 2018. The device falls under product code LQD (Recorder, Attention Task Performance), a Class U device. The Tova Company has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2018
Date Received
December 22, 2017
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 by The Tova Company

  • K170082 — Test of Variables of Attention (T.O.V.A.) Version 9.0 (May 17, 2017)

Other clearances for product code LQD

  • 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)
  • K020800 — OPTAX SYSTEM (June 10, 2002)
  • 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