Cleared Traditional

SILVER LD MODULE, ITE (K933044) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K933044 · Electone, Inc. · Ear, Nose, Throat device
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Aug 1993
Decision
96d
Days
Class 1
Risk

K933044 is an FDA 510(k) clearance for the SILVER LD MODULE, ITE. Classified as Face Plate Hearing Aid (product code LRB), Class I - General Controls.

Submitted by Electone, Inc. (Longwood, US). The FDA issued a Cleared decision on August 2, 1993 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - the FDA ear, nose and throat device framework. 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 Electone, Inc. devices

Submission Details

510(k) Number K933044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1993
Decision Date August 02, 1993
Days to Decision 96 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 89d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRB Face Plate Hearing Aid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.