Cleared Traditional

K851744 - EQUITEST

K851744 · Neurocom International, Inc. · Ear, Nose, Throat device
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Aug 1985
Decision
98d
Days
-
Risk

K851744 is an FDA 510(k) clearance for the EQUITEST. Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Neurocom International, Inc. (Portland, US). The FDA issued a Cleared decision on August 5, 1985 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Neurocom International, Inc. devices

FDA 510(k) Submission Details - K851744

510(k) Number K851744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1985
Decision Date August 05, 1985
Days to Decision 98 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 90d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

LXV Device Classification - Class 0,

Product Code LXV Apparatus, Vestibular Analysis
Device Class -