INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER

Audiometer

IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)

The following data is part of a premarket notification filed by Idem (int'l Dist. Of Electronics For Medicine) with the FDA for Interacoustics Model Ad229 Diagnostic Audiometer.

Pre-market Notification Details

Device IDK982249
510k NumberK982249
Device Name:INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER
ClassificationAudiometer
Applicant IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) 4814 EAST SECOND ST. Benicia,  CA  94510
ContactDonna Ward
CorrespondentDonna Ward
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) 4814 EAST SECOND ST. Benicia,  CA  94510
Product CodeEWO  
CFR Regulation Number874.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-06-26
Decision Date1998-08-07
Summary:summary

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