DISETRONIC D-TRON INSULIN INFUSION PUMP

Pump, Infusion, Insulin

DISETRONIC MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Disetronic Medical Systems with the FDA for Disetronic D-tron Insulin Infusion Pump.

Pre-market Notification Details

Device IDK994186
510k NumberK994186
Device Name:DISETRONIC D-TRON INSULIN INFUSION PUMP
ClassificationPump, Infusion, Insulin
Applicant DISETRONIC MEDICAL SYSTEMS 7690 CAMERON CIRCLE Ft. Meyers,  FL  33912
ContactLee Leichter
CorrespondentLee Leichter
DISETRONIC MEDICAL SYSTEMS 7690 CAMERON CIRCLE Ft. Meyers,  FL  33912
Product CodeLZG  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-10
Decision Date1999-12-30
Summary:summary

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