ACIST INJECTOR SYSTEM, MODEL CL100 H

Injector, Contrast Medium, Automatic

ACIST MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Acist Medical Systems with the FDA for Acist Injector System, Model Cl100 H.

Pre-market Notification Details

Device IDK984058
510k NumberK984058
Device Name:ACIST INJECTOR SYSTEM, MODEL CL100 H
ClassificationInjector, Contrast Medium, Automatic
Applicant ACIST MEDICAL SYSTEMS 10250 VALLEY VIEW RD., #117 Eden Prairie,  MN  55344
ContactKate Anderson
CorrespondentKate Anderson
ACIST MEDICAL SYSTEMS 10250 VALLEY VIEW RD., #117 Eden Prairie,  MN  55344
Product CodeIZQ  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-13
Decision Date1999-02-11
Summary:summary

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