IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P

Audiometer

SINGER MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Singer Medical Products, Inc. with the FDA for Impedance Anal/screening Audiometer Md-1 & Md-1p.

Pre-market Notification Details

Device IDK894748
510k NumberK894748
Device Name:IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P
ClassificationAudiometer
Applicant SINGER MEDICAL PRODUCTS, INC. 790 MAPLE LN. Bensenville,  IL  60106
ContactJames I Beck
CorrespondentJames I Beck
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 Received1989-07-26
Decision Date1989-12-05

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