MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311

Accessories, Pump, Infusion

MINIMED, INC.

The following data is part of a premarket notification filed by Minimed, Inc. with the FDA for Medtronic Minimed Comlink, Hardware Model 7304 & Software Model 7311.

Pre-market Notification Details

Device IDK021974
510k NumberK021974
Device Name:MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311
ClassificationAccessories, Pump, Infusion
Applicant MINIMED, INC. 18000 DEVONSHIRE ST. Northridge,  CA  91325
ContactGerda Resch
CorrespondentGerda Resch
MINIMED, INC. 18000 DEVONSHIRE ST. Northridge,  CA  91325
Product CodeMRZ  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-17
Decision Date2002-08-06
Summary:summary

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