ANGIOGRAPHIC SYSTEM

System, X-ray, Angiographic

ACOMA MEDICAL IMAGING, INC.

The following data is part of a premarket notification filed by Acoma Medical Imaging, Inc. with the FDA for Angiographic System.

Pre-market Notification Details

Device IDK944952
510k NumberK944952
Device Name:ANGIOGRAPHIC SYSTEM
ClassificationSystem, X-ray, Angiographic
Applicant ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling,  IL  60090
ContactJames Lambrecht
CorrespondentJames Lambrecht
ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling,  IL  60090
Product CodeIZI  
CFR Regulation Number892.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-07
Decision Date1995-02-17

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