HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR

Analyzer, Heparin, Automated

MEDTRONIC PERFUSION SYSTEMS

The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Heparin Dose Response Controls, Model 306-20 Por.

Pre-market Notification Details

Device IDK051040
510k NumberK051040
Device Name:HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
ClassificationAnalyzer, Heparin, Automated
Applicant MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis,  MN  55038
ContactBruce Backlund
CorrespondentBruce Backlund
MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis,  MN  55038
Product CodeJOX  
CFR Regulation Number864.5680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-25
Decision Date2005-05-24
Summary:summary

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