HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)

Analyzer, Heparin, Automated

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Hemostasis Managment System Plus (hms-plus).

Pre-market Notification Details

Device IDK111339
510k NumberK111339
Device Name:HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
ClassificationAnalyzer, Heparin, Automated
Applicant MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View,  MN  55112
ContactAmra Racic
CorrespondentAmra Racic
MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View,  MN  55112
Product CodeJOX  
CFR Regulation Number864.5680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-12
Decision Date2011-06-08
Summary:summary

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