DSP SCREENING AUDIOMETER

Audiometer

MICRO AUDIOMETRICS CORP.

The following data is part of a premarket notification filed by Micro Audiometrics Corp. with the FDA for Dsp Screening Audiometer.

Pre-market Notification Details

Device IDK924543
510k NumberK924543
Device Name:DSP SCREENING AUDIOMETER
ClassificationAudiometer
Applicant MICRO AUDIOMETRICS CORP. 2200 SO. RIDGEWOOD AVENUE, US#1 South Daytona,  FL  32119
ContactLarry Debernardo
CorrespondentLarry Debernardo
MICRO AUDIOMETRICS CORP. 2200 SO. RIDGEWOOD AVENUE, US#1 South Daytona,  FL  32119
Product CodeEWO  
CFR Regulation Number874.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-08
Decision Date1993-02-26

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