AE-105D DIAGNOSTIC TYMPANOMETER— 510(k) K894260

Name: FDA 510(k) clearance K894260
Creator: U.S. Food and Drug Administration
Published: 1990-01-23

Substantially Equivalent

American Electromedics Corp.

FDA 510(k) clearance K894260 for AE-105D DIAGNOSTIC TYMPANOMETER, Substantially Equivalent on 1990-01-23. Applicant: American Electromedics Corp.. Device class: 2.

Clearance details

Applicant: American Electromedics Corp.
Product code: Code ETY
Device class: Class 2
Regulation: 21 CFR 874.1090
Advisory panel: Ear, Nose, Throat
Date received: 1989-06-20
Decision date: 1990-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hudson, NH, US

Download summary PDF View on FDA.gov ↗

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K983046 — AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER1998-11-17
K983048 — AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER1998-11-17
K972221 — K 15 AUDIOMETER1997-09-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.