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510(k) K143468

QbCheck by Qbtech AB — Product Code LQD

K143468 is an FDA 510(k) premarket notification submitted by Qbtech AB for the device "QbCheck". The FDA issued a decision of Substantially Equivalent on March 22, 2016. The device falls under product code LQD (Recorder, Attention Task Performance), a Class U device. Qbtech AB has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2016
Date Received
December 4, 2014
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 Qbtech AB

  • K133382 — QB TEST (March 24, 2014)
  • K122149 — QBTES (October 17, 2012)
  • K040894 — QBTEST (June 22, 2004)

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)
  • 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