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 IDK071613
510k NumberK071613
Device Name:AMIGO INSULIN PUMP
ClassificationPump, Infusion, Insulin
Applicant NIPRO DIABETES SYSTEMS, INC. 3361 ENTERPRISE PKWY. Miramar,  FL  33025
ContactHarry Russell
CorrespondentHarry Russell
NIPRO DIABETES SYSTEMS, INC. 3361 ENTERPRISE PKWY. Miramar,  FL  33025
Product CodeLZG  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-06-13
Decision Date2007-12-14
Summary:summary

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