INFUTEST 2000 INFUSION DEVICE ANALYZER

Accessories, Pump, Infusion

DATREND SYSTEMS, INC.

The following data is part of a premarket notification filed by Datrend Systems, Inc. with the FDA for Infutest 2000 Infusion Device Analyzer.

Pre-market Notification Details

Device IDK980165
510k NumberK980165
Device Name:INFUTEST 2000 INFUSION DEVICE ANALYZER
ClassificationAccessories, Pump, Infusion
Applicant DATREND SYSTEMS, INC. UNIT 106-3070 NORLAND AVE. Burnaby, British Columbia,  CA V5b 3a6
ContactRon Evans
CorrespondentRon Evans
DATREND SYSTEMS, INC. UNIT 106-3070 NORLAND AVE. Burnaby, British Columbia,  CA V5b 3a6
Product CodeMRZ  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-16
Decision Date1998-04-20
Summary:summary

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