Cleared Traditional

EQUITEST (K851744) - FDA 510(k) Clearance

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

Submission Details

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
9d slower than avg
Panel avg: 89d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXV Apparatus, Vestibular Analysis
Device Class -

Regulatory Peers - LXV Apparatus, Vestibular Analysis

All 21
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