FLO-GARD 8000 COMPUTER CONTROL INFUSI

Controller, Infusion, Intravascular, Electronic

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Flo-gard 8000 Computer Control Infusi.

Pre-market Notification Details

Device IDK834154
510k NumberK834154
Device Name:FLO-GARD 8000 COMPUTER CONTROL INFUSI
ClassificationController, Infusion, Intravascular, Electronic
Applicant TRAVENOL LABORATORIES, S.A. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLDR  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-12-02
Decision Date1984-01-25

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