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510(k) K911938

DYNAVISION 2000 by Performance Ent. — Product Code LQD

K911938 is an FDA 510(k) premarket notification submitted by Performance Ent. for the device "DYNAVISION 2000". The FDA issued a decision of Substantially Equivalent on August 2, 1991. The device falls under product code LQD (Recorder, Attention Task Performance), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1991
Date Received
May 1, 1991
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)
  • 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)
  • K861304 — FAGAN TEST MACHINE FOR INFANT INTELLIGENCE (September 23, 1986)
  • K854903 — GORDON DIAGNOSTIC SYSTEM MODEL I (June 2, 1986)

FDA data resources