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510(k) K141865

DANA by Anthrotronix, Inc. — Product Code LQD

K141865 is an FDA 510(k) premarket notification submitted by Anthrotronix, Inc. for the device "DANA". The FDA issued a decision of Substantially Equivalent on October 15, 2014. The device falls under product code LQD (Recorder, Attention Task Performance), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2014
Date Received
July 10, 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

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  • K143468 — QbCheck (March 22, 2016)
  • 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