Cleared Traditional

K883478 - DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602

K883478 is an FDA 510(k) clearance for DIAGNOSTIC AUDIOMETER, manufactured by Madsen Electronics (Canada) , Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K883478 · Madsen Electronics (Canada) , Ltd. · Ear, Nose, Throat device
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Nov 1988
Decision
93d
Days
Class 2
Risk

K883478 is an FDA 510(k) clearance for the DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Madsen Electronics (Canada) , Ltd. (Oakville, Ontario, CA). The FDA issued a Cleared decision on November 17, 1988 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - 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 Madsen Electronics (Canada) , Ltd. devices

FDA 510(k) Submission Details - K883478

510(k) Number K883478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1988
Decision Date November 17, 1988
Days to Decision 93 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 90d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWO Device Classification - Class 2, Special Controls

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EWO Audiometer

All 130
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K883478.
2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY
K890842 · Maico Hearing Instruments, Inc. · Jun 1989
AUDIOSCOPE 3 MODEL 23300 ACCESSORIES
K884218 · Welch Allyn, Inc. · Mar 1989
AUDIOMETER DIGITAL HEARING SYSTEM
K884044 · Resound Corp. · Feb 1989
AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER
K881760 · American Electromedics Corp. · Jun 1988
THE BELTONE 2000 AUDIOMETER
K875360 · Beltone Electronics Corp. · Feb 1988
PHOENIX SYSTEM SEVEN.
K862592 · Nicolet Biomedical Instruments · Sep 1986