Cleared Traditional

K930164 - THE AUTOMATIC IMPEDANCE METER

K930164 is an FDA 510(k) clearance for THE AUTOMATIC IMPEDANCE METER, manufactured by American Electromedics Corp.. The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K930164 · American Electromedics Corp. · Ear, Nose, Throat device
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Apr 1993
Decision
100d
Days
Class 2
Risk

K930164 is an FDA 510(k) clearance for the THE AUTOMATIC IMPEDANCE METER,MODEL AE-208D/S. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by American Electromedics Corp. (Amherst, US). The FDA issued a Cleared decision on April 23, 1993 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1090 - 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 American Electromedics Corp. devices

FDA 510(k) Submission Details - K930164

510(k) Number K930164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1993
Decision Date April 23, 1993
Days to Decision 100 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
11d slower than avg
Panel avg: 89d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETY Device Classification - Class 2, Special Controls

Product Code ETY Tester, Auditory Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1090
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 - ETY Tester, Auditory Impedance

All 11
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