Cleared Traditional

K884926 - BALANCE SYSTEM (FDA 510(k) Clearance)

K884926 · Chattanooga Group, Inc. · Ear, Nose, Throat device
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Feb 1989
Decision
91d
Days
-
Risk

K884926 is an FDA 510(k) clearance for the BALANCE SYSTEM. Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Chattanooga Group, Inc. (Red Bank, US). The FDA issued a Cleared decision on February 27, 1989 after a review of 91 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.

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Submission Details

510(k) Number K884926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1988
Decision Date February 27, 1989
Days to Decision 91 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
2d slower than avg
Panel avg: 89d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXV Apparatus, Vestibular Analysis
Device Class -