EARSCAN 3

Audiometer

MICRO AUDIOMETRICS CORP.

The following data is part of a premarket notification filed by Micro Audiometrics Corp. with the FDA for Earscan 3.

Pre-market Notification Details

Device IDK982878
510k NumberK982878
Device Name:EARSCAN 3
ClassificationAudiometer
Applicant MICRO AUDIOMETRICS CORP. 2200 SO.RIDGEWOOD AVE. South Daytona,  FL  32119 -3018
ContactJason R Keller
CorrespondentJason R Keller
MICRO AUDIOMETRICS CORP. 2200 SO.RIDGEWOOD AVE. South Daytona,  FL  32119 -3018
Product CodeEWO  
CFR Regulation Number874.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-14
Decision Date1998-11-03
Summary:summary

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