AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER

Tester, Auditory Impedance

AMERICAN ELECTROMEDICS CORP.

The following data is part of a premarket notification filed by American Electromedics Corp. with the FDA for American Electromedics Race Ca Tympanometer/audiometer With Integral Printer.

Pre-market Notification Details

Device IDK983051
510k NumberK983051
Device Name:AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
ClassificationTester, Auditory Impedance
Applicant AMERICAN ELECTROMEDICS CORP. P.O. BOX 9169 Chico,  CA  95927
ContactFrank Ferguson
CorrespondentFrank Ferguson
AMERICAN ELECTROMEDICS CORP. P.O. BOX 9169 Chico,  CA  95927
Product CodeETY  
CFR Regulation Number874.1090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-01
Decision Date1998-11-18
Summary:summary

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