510(k) K170082

Test of Variables of Attention (T.O.V.A.) Version 9.0 by The Tova Company — Product Code LQD

K170082 is an FDA 510(k) premarket notification submitted by The Tova Company for the device "Test of Variables of Attention (T.O.V.A.) Version 9.0". The FDA issued a decision of Substantially Equivalent on May 17, 2017. 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
May 17, 2017
Date Received
January 10, 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