Cleared Traditional

DYNAVISION 2000 (K911938) - FDA 510(k) Clearance

K911938 · Performance Ent. · Neurology device
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Aug 1991
Decision
93d
Days
-
Risk

K911938 is an FDA 510(k) clearance for the DYNAVISION 2000. Classified as Recorder, Attention Task Performance (product code LQD).

Submitted by Performance Ent. (Canada, L3r 2a7, CA). The FDA issued a Cleared decision on August 2, 1991 after a review of 93 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 K911938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1991
Decision Date August 02, 1991
Days to Decision 93 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 148d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQD Recorder, Attention Task Performance
Device Class -