EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE

Accessories, Pump, Infusion

ANIMAS CORP.

The following data is part of a premarket notification filed by Animas Corp. with the FDA for Ez Manager Max Diabetes Management Software.

Pre-market Notification Details

Device IDK080587
510k NumberK080587
Device Name:EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE
ClassificationAccessories, Pump, Infusion
Applicant ANIMAS CORP. 200 LAWRENCE DR. West Chester,  PA  19380
ContactJennifer Bosley
CorrespondentJennifer Bosley
ANIMAS CORP. 200 LAWRENCE DR. West Chester,  PA  19380
Product CodeMRZ  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-03
Decision Date2008-05-15
Summary:summary

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