MODEL ESP-200 MAMMOGRAPHIC SYSTEM

System, X-ray, Mammographic

ACOMA MEDICAL IMAGING, INC.

The following data is part of a premarket notification filed by Acoma Medical Imaging, Inc. with the FDA for Model Esp-200 Mammographic System.

Pre-market Notification Details

Device IDK884345
510k NumberK884345
Device Name:MODEL ESP-200 MAMMOGRAPHIC SYSTEM
ClassificationSystem, X-ray, Mammographic
Applicant ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling,  IL  60090
ContactJohn W Lee
CorrespondentJohn W Lee
ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling,  IL  60090
Product CodeIZH  
CFR Regulation Number892.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-14
Decision Date1989-03-23

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