H-TRON V 100 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 H-tron V 100 Insulin Infusion Pump.

Pre-market Notification Details

Device IDK905693
510k NumberK905693
Device Name:H-TRON V 100 INSULIN INFUSION PUMP
ClassificationPump, Infusion, Insulin
Applicant DISETRONIC MEDICAL SYSTEMS 13911 RIDGEDALE DR. SUITE 254 Minnetonka,  MN  55343
ContactJim Myers
CorrespondentJim Myers
DISETRONIC MEDICAL SYSTEMS 13911 RIDGEDALE DR. SUITE 254 Minnetonka,  MN  55343
Product CodeLZG  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-19
Decision Date1991-04-12

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