MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER

Pump, Infusion, Insulin

MINIMED, INC.

The following data is part of a premarket notification filed by Minimed, Inc. with the FDA for Medtronic Minimed Paradigm Model 512 Insulin Pump And The Bd Paradigm Link Glucose Meter.

Pre-market Notification Details

Device IDK030531
510k NumberK030531
Device Name:MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER
ClassificationPump, Infusion, Insulin
Applicant MINIMED, INC. 18000 DEVONSHIRE ST. Northridge,  CA  91325
ContactGerda P Resch
CorrespondentGerda P Resch
MINIMED, INC. 18000 DEVONSHIRE ST. Northridge,  CA  91325
Product CodeLZG  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2003-02-19
Decision Date2003-06-17
Summary:summary

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