MD5 AUTOMATIC AUDIOMETER

Audiometer

SINGER MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Singer Medical Products, Inc. with the FDA for Md5 Automatic Audiometer.

Pre-market Notification Details

Device IDK896909
510k NumberK896909
Device Name:MD5 AUTOMATIC AUDIOMETER
ClassificationAudiometer
Applicant SINGER MEDICAL PRODUCTS, INC. 790 MAPLE LN. Bensenville,  IL  60106
ContactJames W Schwartz
CorrespondentJames W Schwartz
SINGER MEDICAL PRODUCTS, INC. 790 MAPLE LN. Bensenville,  IL  60106
Product CodeEWO  
CFR Regulation Number874.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-11
Decision Date1990-03-05

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