Cleared Traditional

K173915 - Test of Variables of Attention (T.O.V.A.) (FDA 510(k) Clearance)

K173915 · The Tova Company · Neurology device
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Mar 2018
Decision
90d
Days
-
Risk

K173915 is an FDA 510(k) clearance for the Test of Variables of Attention (T.O.V.A.). Classified as Recorder, Attention Task Performance (product code LQD).

Submitted by The Tova Company (Portland, US). The FDA issued a Cleared decision on March 22, 2018 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K173915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2017
Decision Date March 22, 2018
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQD Recorder, Attention Task Performance
Device Class -