AMIGO INSULIN PUMP

Pump, Infusion, Insulin

NIPRO DIABETES SYSTEMS, INC.

The following data is part of a premarket notification filed by Nipro Diabetes Systems, Inc. with the FDA for Amigo Insulin Pump.

Pre-market Notification Details

Device IDK050312
510k NumberK050312
Device Name:AMIGO INSULIN PUMP
ClassificationPump, Infusion, Insulin
Applicant NIPRO DIABETES SYSTEMS, INC. 3361 ENTERPRISE WAY Miramar,  FL  33025
ContactClarence Odom
CorrespondentClarence Odom
NIPRO DIABETES SYSTEMS, INC. 3361 ENTERPRISE WAY Miramar,  FL  33025
Product CodeLZG  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-08
Decision Date2005-05-09
Summary:summary

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