INFUSION PUMP, MODEL NO. UDP-5

Device, Cystometric, Hydraulic

LABORIE MEDICAL TECHNOLOGIES, LTD.

The following data is part of a premarket notification filed by Laborie Medical Technologies, Ltd. with the FDA for Infusion Pump, Model No. Udp-5.

Pre-market Notification Details

Device IDK942023
510k NumberK942023
Device Name:INFUSION PUMP, MODEL NO. UDP-5
ClassificationDevice, Cystometric, Hydraulic
Applicant LABORIE MEDICAL TECHNOLOGIES, LTD. 7 GREEN TREE DR. #4 South Burlington,  VT  05403
ContactFred Buffa
CorrespondentFred Buffa
LABORIE MEDICAL TECHNOLOGIES, LTD. 7 GREEN TREE DR. #4 South Burlington,  VT  05403
Product CodeFEN  
CFR Regulation Number876.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-26
Decision Date1994-07-12

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